Total 290 Director/C-Level Quality Assurance / Control job vacancies

The Vacancy

Are you passionate about inspiring excellence and driving strategic quality initiatives? Do you thrive in a dynamic environment where innovation and improvement are encouraged? If so, we invite you to apply for the position of Director of Quality at Lewisham College.

Role Overview: As the Director of Quality, you will play a pivotal role in championing the highest performance standards across our institution. You'll be a key member of our senior leadership team, entrusted with the responsibility of steering our quality assurance and improvement systems to new heights. Your leadership will be instrumental in fostering a culture of self-assessment and continuous enhancement to align with our College's strategic and operational goals.

Responsibilities:

Provide visionary and strategic leadership to uphold and elevate performance standards.
Lead the development and implementation of efficient quality assurance and improvement systems.
Collaborate closely with Senior Management to align quality initiatives with organisational objectives.
Cultivate a culture of self-assessment and continuous improvement among staff and stakeholders.
Monitor and evaluate the effectiveness of quality processes, making data-driven recommendations for enhancement.
Foster a collaborative and supportive environment conducive to innovation and excellence.


About Lewisham College

Lewisham College is a large further education college in London and we’re proud of our reputation for producing knowledgeable, successful students with great employment potential. We offer an exciting range of work-focused courses, and provide a friendly, supportive learning environment where talent is nurtured.

We have achieved excellent results in recent years, but we know that we can only continue our success, and grow, by recruiting and retaining the best possible talent. We set out to employ staff with a genuine passion for further education and a commitment to ensuring all students achieve their potential, whatever barriers they need to overcome. Our people make a real difference not only to the lives of students, but also to local employers and the wider Lewisham community.

Every colleague has a valuable and important part to play here at Lewisham College and all of our employees are well-supported. We offer a wide range of staff development programmes, benefits and support all designed to enable our people to continually improve and reward them for their hard work and dedication. If you have a passion for education and its power to improve lives, and want to inspire young people and adults, we’d love to welcome you to our team.

Lewisham College is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults. We expect all staff to share this commitment.

At Lewisham College, our values are not just about what we do, but also about how we do things.

Our values underpin the culture and beliefs of our organisation, we expect all our staff to demonstrate behaviours in line with our core values.

1. Being both inclusive and diverse

2. Trusting and respecting our communities

3. Taking ownership whilst working collaboratively

4. Inspiring excellence and curiosity.

As part of the NCG Group, Lewisham College offers an excellent benefits package, including generous holiday entitlement, access to the Teachers’ pension scheme (for teaching posts) or Local Government pension scheme (non-teaching posts), company sick pay, a cycle to work scheme and much more.

NCG seeks to promote and maintain an equal, diverse, inclusive and supportive environment for work and study that assists all members of our communities to reach their full potential. We are committed to achieving a truly representative workforce and therefore welcome applications from across the national and regional communities that we work with and serve.

No agency applications will be accepted.

NCG reserve the right to close the vacancy early.

Proud member of the Disability Confident employer scheme

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

POSITION SUMMARY:

Under the direction of the compliance function reporting directly to the Deputy Compliance Officer (“DCO”) this position owns the anti-corruption compliance program for Illumina’s markets in AMEA and Greater China (“AMEA/China Markets”). The DCO ensures that the AMEA/China Markets anti-corruption compliance program is aligned with the 7 Effective Elements of a compliance program as well as the companywide Corporate Compliance Program. This position is responsible for the development, improvement, and day to day activities/management of AMEA/China Markets anti-corruption compliance program and system. With direction from the CCO and DCO this position is also responsible for implementing anti-corruption compliance standards and procedures and ensuring that these standards are communicated and institutionalized throughout the AMEA/China Markets. This position serves as the local subject matter expert on Anticorruption topics or functions.  This position requires the ability to be a business partner. This position will collaborate with the compliance functions in the Americas and Europe to ensure regional alignment with the Corporate Compliance Program.  This position will also need to team with the Investigations function responsible for anti-corruption investigations when necessary.

PRINCIPAL RESPONSIBILITIES:

• Develop, implement, and execute an anti-corruption risk assessment including ranking of risks and identification of risk mitigation plans for AMEA/China Markets.  Include compliance risks associated with local anti-corruption laws and regulations.
• Align the AMEA/China Markets anti-corruption compliance program with the 7 Effective Elements of compliance program and the global Illumina Corporate Compliance Program.
• Assist in developing and implementing AMEA/China Markets anti-corruption policies and procedures designed to ensure full compliance with legal, regulatory, accounting, and contractual requirements.
• Administer AMEA and Greater China quarterly Regional Compliance Committee meetings. 
• Develop, distribute, and deliver effective training and communications in support of the AMEA/China Markets anti-corruption compliance program and Illumina’s Corporate Compliance Program, including language localizations as appropriate.
• Promote awareness of the AMEA/China Markets anti-corruption compliance program and Illumina’s Corporate Compliance Program.
• Communicate compliance related information regarding the above-mentioned risks with the AMEA/China Markets commercial leads.
• Periodically measure the effectiveness of the AMEA/China Markets anti-corruption compliance program to develop and implement appropriate recommendations.
• Work with Internal Audit to monitor compliance with compliance policies through the use of periodic audits.
• Collaborate closely with internal stakeholders- HR, Internal Audit, Finance, Commercial, Global Trade Compliance, and Supply Chain to identify, mitigate and resolve anti-corruption compliance matters.
• Lead cross-functional project teams as needed to implement anti-corruption compliance initiatives.
• Partner with the Director of Global Compliance Operations and Channel Partner Compliance to manage and run the Channel Partner due diligence process, Channel Partner training, and annual Channel Partner certifications for AMEA/China Markets.
• Assist with compliance and ethics related investigations, inspections, and audits in coordination with the CCO, DCO, and Investigations function.  Follow up on compliance and ethics related investigations to ensure recommendations have been appropriately and timely implemented.
• Coordinate and report activities to the Chief Compliance Officer on a quarterly basis regarding anti-corruption compliance initiatives, training, and results of compliance evaluations.
• Participates in the development of AMEA/China Markets’ annual anti-corruption compliance budget and ensure expenditures remain within the budgeted expectations.
• Performs other duties as assigned or required to help ensure an effective AMEA/China Markets anti-corruption compliance program.

EDUCATION / EXPERIENCE REQUIREMENTS:

• A bachelor’s degree is required, with a degree in accounting, finance, legal studies, or related field being a plus.

• A minimum of 7 to 10 years of legal, corporate compliance or similar experience preferably with a multinational organization similar to Illumina.
• Familiarity with laws and regulations associated with the above risks and related controls is required.
• Certification or advanced degree a plus.

SPECIALIZED SKILLS & OTHER REQUIREMENTS:

• Strong sense of integrity, business transaction transparency and the ability to balance business interests with the need to exercise independent judgment.
• Thorough knowledge of Anticorruption compliance, including The 7 Effective Elements of a Compliance Program.
• Organized, energetic, flexible and self-motivated, with an analytical mind.  Able to gather, analyze, evaluate facts, and reach appropriate conclusions.  Able to work independently, often without assistance or on-site supervision.
• Strong time management and document management skills with a fine attention to detail.
• Willing and able to travel (up to 25%) including International.
• Ability to communicate clearly and effectively at all levels of the company, both orally and in writing is essential for this role.
• Proficient in use of Microsoft Office software.  Emphasis on excel and SharePoint
• Strong diplomatic skills, patience, and the proven ability to find creative, business-friendly solutions.
• Strong people and customer service skills.
• Able to establish and maintain effective working relationships within Illumina.  Able to gain the confidence, respect and trust of Illumina Business Units through attributes such as professionalism and positive attitude.
• Is respected throughout the organization by individuals.
• Is sought out by management for input on Anticorruption compliance matters.
• Excellent project management and process improvement skills.
• Ability to maintain a flexible work schedule (able to meet the requirements of the position as needed, including ability to work evenings and weekends, with or without advanced notice)
• Identifies Anticorruption compliance risks throughout the year and brings those to the attention of the Chief Compliance Officer.

TRAVEL REQUIRED: Up to 25%

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Job Description

General Summary:

The Senior Director, Quality GLP, Biomarkers and Research has overall accountability for strategic leadership and oversight of the end-to-end quality assurance strategy for proactive, risk-informed, and sustainable quality oversight and compliance with regulatory expectations across Vertex processes for clinical evidence generation and product vigilance

Key Duties and Responsibilities:
• Serves as a strategic partner to functional leaders across product modalities responsible for Research (including both non-regulated and GLP work), Biomarker Development, and Diagnostics in assuring appropriate quality/compliance oversight of processes and systems supporting effective delivery of these programs and the rigor and integrity of associated data.
• Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors. Assures operational quality activities are informed by risk and assure the integrity of data submitted to regulatory authorities and in external forums.
• Responsible for assuring that key research & pre-clinical studies (internal and external) are performed in accordance with good scientific practices, good laboratory practices, Vertex policies and procedures and relevant local, regional, and international requirements.
• Leads an operational quality team responsible for identifying and anticipating potential compliance issues that may impact the ability to meet business goals, developing and implementing methods of improvement and resolution in a pragmatic and effective manner
• Oversees effective, timely, and appropriate identification, remediation, and escalation of quality issues in key Research, GLP, Biomarker, IVD and vendor governance-related activities across Vertex.
• Provides periodic updates on the overall health of Research, GLP, Biomarker, and IVD development-related processes and systems to functional leaders across Research, Biomarker Development, and Diagnostics.
• Oversees and assures timely and effective communication of summary trending and other insights on the quality of delivery in research, preclinical, biomarker, IVD work, and vendor performance to relevant business and quality leaders and in relevant forums.
• Oversees Inspection Readiness activities in collaboration with business and Quality Assurance partners related to research, GLP, biomarkers, IVD development activities.
• Chairs relevant operational governance meetings (e.g. QLT)
• Serves as the R&D Quality lead and oversees and guides staff participating in strategic cross-functional initiatives (e.g. Research Ethics, TRPM to improve quality, data integrity, and compliance to regulatory requirements and standards, ensuring a aligned Quality point-of-view is represented.
• Maintains an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Research, GLP, Biomarker, and IVD activities.
• Drives and oversees implementation of new and evolving regulatory requirements related to areas of responsibility.
• Leads and/or participates in industry forums and external initiatives related to areas of responsibility to influence policy development related to oversight of these activities, as aligned with functional leadership and Vertex interests.
• Provides strategic direction, oversight, coaching and mentoring to direct reports.

Education and Experience:

• M.S. (or equivalent degree) and 10 +years of relevant work experience, or
• B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience, or relevant comparable background

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

Company Information

Job Description

As a part of our Global Anti Bribery & Corruption (ABAC) Program (“the Team”), Associate Director, Compliance Data Risk Analytics & Monitoring will have responsibility for the management of the Company’s global compliance risk data monitoring program for certain ex-US regions.

In addition, the Associate Director work with the Team to conduct above-region analytics and monitoring focused on transfer of value compliance risk and other compliance projects.  The responsibilities will involve cross-functional interface with region and market functions, including Human Health International, International Commercial Operations, and International Legal & Compliance.  

 

Reporting directly to the Executive Director, Global Anti Bribery & Corruption Program, this position is based out of our Headquarter site in Rahway (NJ) with a hybrid setup (combination of an in-office & remote). This position cannot be 100% remote.

 

Current Position Responsibilities:

• Drive business ownership. Help the team lead the development and sustainability of the global compliance data risk monitoring and analytics platform and program.   
• Serve as primary advisor to develop in-depth understanding and expertise in Compliance data risk identification, monitoring and remediation for all markets within the regions.
• Collaborate with the Data analytics team and ABAC Operations to provide consistent and aligned guidance to the select markets and regions.
• Build analytical data risk models that identify, and monitor risk based on internal and external market events and implement innovative solutions to risk monitoring and illustrations.
• Interpret the analyses of complex compliance risk data and communicate/present the data findings in an understandable way to market/regional colleagues in the business. 
• Conduct data analyses using (e.g. Concur, SAP, etc.), events (Veeva CRM) and other systems data.
• Develop and conduct training process aspects of monitoring tool and associated risks.
• Ability to solve complex problems with an in-depth understanding of local market requirements.

 

 

Required Experience and Skills:  

• Min 2 years of credible experience in analytical & quantitative skills including and not limited to analyzing and interpreting large complex datasets to identify potential compliance risk trends focused on transfer of value risk. 
• Demonstrated capability to manipulate, analyze and interpret commercial risk data, simplify complex information/processes within the team and communicate the risk trends or issues with senior stakeholders.
• Min 2 years of experience with financial reporting, master data management and customer relationship management systems.
• Ability to work well within global cross-functional teams and collaborate effectively within all levels of the organization.
• Elevated Project Management skills with ability to effectively manage and complete projects within agreed-to timelines.   
• An out of the box thinker who has ability to work independently, is solution oriented, proactive, has good judgment and “growth mindset”.
• Ability to work with agility in a fast-paced, multi-task environment that demands initiative and responsiveness.
• Excellent communication (written and oral), presentation and organization skills.
• Data analyses /data mining tools using (Concur, SAP, etc.), events (Veeva CRM) and other systems data.

 

Preferred Experience and Skills:

• Pharmaceutical experience with a focus on business practices and compliance  
• Global experience.

 

Education:

• BS/BA degree and/or equivalent degree.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$122,800.00 - $193,300.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

About the role:
Sustainalytics is currently seeking a Chief Compliance Officer. The Chief Compliance Officer, will be responsible for the implementation of the Sustainalytics Global Compliance Program. This is a position based in our offices in Amsterdam and reports to the Global Chief Compliance Officer (“GCCO”) Ratings and Benchmarks
 

Job responsibilities:
Given the current market and regulatory environment, many rules and regulations have been enacted around the global. These rules and regulations continue to be updated. This role will be part of the Global Compliance team – with other members working in Toronto, New York, Bucharest, Madrid and Mumbai. The Chief Compliance Officer is responsible for ensuring the Firm’s policies and procedures ensure compliance with the European regulatory scheme and ensuring staff understand their responsibilities under the rules and regulations.

In this role, the successful candidate will have the ability to shape the role and have a meaningful impact. The Chief Compliance Officer will be expected to do the following:

• Responsible for the compliance program to meet the regulatory frameworks enacted in Europe (including UK), and provide ongoing assurance of compliance with Sustainalytics policies and procedures
• Provide advice and guidance to management on matters relating to conduct and compliance, including identifying areas of compliance vulnerability and risk, based on findings of compliance reviews
• Lead on the compliance component on the development of new business processes, and on changes to current business processes arising from changes to European regulations
• Enhance standard procedures for the intake (including for anonymous reporting and complaints from third parties), investigation, escalation and reporting of potential compliance related incidents relating to Sustainalytics to ensure that they are appropriately and consistently evaluated, investigated and resolved
• Foster, and maintain, a good working relationship with ESMA and FCA, compliance colleagues, members of other internal control functions and business management
• Lead the preparation for, and conduct of, regulatory examinations
• Draft any compliance reports required by European regulatory authorities
• Report on existing and emerging compliance issues and risks to the GCCO
• Maintain records of any violation reports received, including details of any actions taken
• Contribute to the ongoing development of the Compliance team by sharing best practices, knowledge, expertise and lessons learned on a regular basis
• Assist with the development, maintenance and delivery of compliance materials and training
• Assist with the continuous improvement of global compliance programs
• Maintain compliance files and records
• Implement and maintain policies and procedures for the general operation of the global compliance program within Sustainalytics.
 

Qualifications:
• 8 years of experience in compliance / regulatory control processes developed in Internal Audit in the Financial Services, Accounting or Legal professions
• Experience in leading and managing complex compliance projects
• Experience in designing and implementing compliance / regulatory policies and procedures
• Experience interacting with and responding to regualtory inquiries
• Experience in providing advice to senior manager and board of directors
• Highly developed interpersonal skills to build and maintain effective internal and external relationships
• Experience managing compliance teams
• Advanced communication skills (verbal and written) to report regulatory compliance information
• Strong analytical and investigative skills and sound judgment
• Understanding/experience of credit rating business would be an advantage
• A bachelor’s degree is required. A law degree is a plus

#LI-PI1

 

315_Sustainalytics SRL Legal Entity

Morningstar’s hybrid work environment gives you the opportunity to work remotely and collaborate in-person each week. We’ve found that we’re at our best when we’re purposely together on a regular basis, at least three days each week. A range of other benefits are also available to enhance flexibility as needs change. No matter where you are, you’ll have tools and resources to engage meaningfully with your global colleagues.

Global Compliance

Our division prevents, detects, and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm’s culture of compliance. Compliance accomplishes these through the firm’s enterprise-wide compliance risk management program. As an independent control function and part of the firm’s second line of defense, Compliance assesses the firm’s compliance, regulatory and reputational risk; monitors for compliance with new or amended laws, rules, and regulations; designs and implements controls, policies, procedures, and training; conducts independent testing; investigates, surveils, and monitors for compliance risks and breaches; and leads the firm’s responses to regulatory examinations, audits and inquiries. You'll be part of a team with members from a wide range of academic and professional backgrounds, such as law, accounting, sales, and trading. We look for those who possess sound judgment, curiosity, and can adapt to a changing regulatory landscape.

Your Impact

The successful candidate will be first member of the Goldman Sachs’ Global Privacy Office in Singapore and will play a critical role in supporting the Firm’s privacy program within the Asian and Pacific region (APAC). This position involves a combination of (i) providing data protection and privacy advisory support to a range of Goldman Sachs businesses operating within the Asia and Pacific region (APAC) and (ii) developing, managing and maturing the Firm’s privacy program in the APAC region and worldwide.

Our Impact

The Global Privacy Office has team members in New York, Chicago, Dallas, London, Warsaw, and is building a team in Bengalaru. The Global Privacy Office works with other privacy and data protection stakeholders at Goldman Sachs, including the Legal, Engineering and Technology Risk teams, Risk, Operations, and the business teams that develop and manage financial products and services.

Responsibilities:

We are seeking a privacy expert who can advise on privacy regulatory matters throughout the APAC region and support the development of the Firm’s privacy program in APAC and worldwide. Key responsibilities for this role include the following:

• Providing privacy advisory guidance to business, engineers, operations, compliance and other stakeholders to enable the delivery and development of privacy compliant business initiatives
• Reviewing and assessing products, features and business activities (including digital marketing activities) against privacy requirements and standards
• Developing privacy design requirements and conducting oversight of the implementation of such requirements
• Reviewing and assessing third party vendors, partnerships and the proposed data integrations from a privacy perspective
• Drafting, editing and reviewing responses to data subject requests and data protection-related queries
• Conducting and supporting the conduct of data protection impact assessments and similar privacy risk assessments
• Drafting and reviewing privacy-related disclosures, including fair processing notices and cookie disclosures
• Providing guidance associated with new and evolving privacy laws and regulations in APAC; supporting and administering cross-functional projects to implement these changes
• Designing, reviewing, maturing and implementing privacy program components throughout the APAC region and around the world
• Implementing and overseeing the effectiveness of privacy controls, privacy enhancing technologies, and privacy risk mitigates
• Creating, reviewing, and revising privacy program policies, procedures, guidance and best practice documents
• Supporting the creation of, and reviewing data processing records and compliance assessments
• Developing and delivering privacy and data protection training.

Skills and Experience We’re Looking For:

• Significant experience advising on privacy regulatory frameworks in the APAC region; experience with privacy regulatory frameworks in other jurisdictions, such as GDPR, CCPA and GLBA, is a plus
• Financial services experience is a plus
• Experience with developing and/or implementing governance frameworks for wide-scale use of cookies and similar tracking technologies
• Experience in a Data Protection Office, Privacy Risk, Privacy Compliance or Privacy Legal function
• Experience advising on direct marketing and online behavioral and targeted advertising, including governance of these practices
• Experience of drafting responses to complaints from data subjects and handling nuanced data subject right requests.
• Experience performing formal and informal risk assessments for new and existing digital products and services from a privacy regulatory perspective
• Strong relationship management skills with ability to deepen relationships and build partnerships across the business, including in Operations, Compliance, Engineering, Legal and Risk
• Comfortable taking the initiative and working across multiple business lines and jurisdictions
• An understanding of digital and retail focused businesses, including new and developing businesses
• Certified Information Privacy Professional accreditation or similar accreditation preferred
• Experience with Microsoft PowerPoint and Excel
• Excellent, written and verbal communication skills; highly organized and sound organizational skills.

About Goldman Sachs

At Goldman Sachs, we commit our people, capital and ideas to help our clients, shareholders and the communities we serve to grow. Founded in 1869, we are a leading global investment banking, securities and investment management firm. Headquartered in New York, we maintain offices around the world.

We believe who you are makes you better at what you do. We're committed to fostering and advancing diversity and inclusion in our own workplace and beyond by ensuring every individual within our firm has a number of opportunities to grow professionally and personally, from our training and development opportunities and firmwide networks to benefits, wellness and personal finance offerings and mindfulness programs. Learn more about our culture, benefits, and people at GS.com/careers.

We’re committed to finding reasonable accommodations for candidates with special needs or disabilities during our recruiting process. Learn more: https://www.goldmansachs.com/careers/footer/disability-statement.html

The Director of Compliance will be responsible for oversight of all quality assurance operations related to the ORR Call Center and execution of project deliverables. The position will act as a member of the leadership team to recommend technological solutions to building awareness, knowledge, and skill; project manage training and reporting deliverables, and will report to the Project Director for the Call Center. 

Key Responsibilities:  

• Oversee and manage the following: 
• Design and operate quality control measures for call center and program oversight.  
• Ensure accuracy and timeliness in execution of all training, QA, and reporting project deliverables.  
• Provide direct oversight of all work streams related to training, QA, and reporting project deliverables. 
• Work closely with the call center staff, ORR (client) and client’s stakeholders in the execution of deliverables and services.  
• Ensure timely and accurate communication with client to ensure transparency and communication of medium and long-term project activities, outstanding issues, and risk mitigation. 
• Enforce uniform development and quality standards and ensure accuracy of project deliverables. 
• Develop monthly reports using available data 
• Directly supervise all subject matter experts in the development of training, FRA/SWB Supervisor and the QA Manager 
• Analyze data collection instruments, tools, and systems to ensure effectiveness and determine when necessary to update or expand systems to provide robust data to the client.  
• Work with clients and SMEs to perform needs assessments to identify critical knowledge, skills, and behaviors; produce gap analyses; and recommend appropriate learning strategies for call center employees 
• Assure all annual and monthly reports are of high quality and delivered according to contract deliverable schedule 

Basic Qualifications:  

• Masters in social services: a Bachelor’s in the same field can be substituted for the MS/MA if accompanied by a minimum of 8 years of training development work in the field of refugee resettlement 
• 3-5 years managing projects or equivalent of project management such as managing multiple aspects of deliverables, deadlines, and partner relationships  
• Minimum of 5 years experience in determining quality of services 
• Minimum of 5 years experience working with a federal client relationship  
• Active Tier 2 security clearance per contract requirements

Preferred Skills/Experience:  

• Experience conducting detailed training and/or job/task analyses  
• Experience developing both soft-skills and technical training  
• Experience with Office of Refugee Resettlement 
• Experience in a Quality Assurance or Continuous Quality Assurance position 
• Experience interacting with and advising clients  

  

Professional Skills:  

• Strong project management skills 
• Strong oral and written communication skills  
• Strong analytical, problem-solving, and decision making capabilities  
• Strong attention to detail  
• Ability to multi-task in a fast-paced environment  
• Ability to work well both individually and in a team environment  
• Ability to prioritize multiple tasks while demonstrating the initiative to complete projects with minimum supervision  
• Ability to work with all levels of internal staff, as well as outside clients and vendors  
• Ability to be flexible to handle multiple priorities and to work limited overtime as necessary  
• Ability to travel up to 25%  
• Proficiency in MS Office Applications (Word, PowerPoint, Outlook, Excel, Project) and MS SharePoint  

  

ICF offers an excellent benefits package, an award-winning talent development program, and fosters a highly skilled, energized and empowered workforce. 

Working at ICF

ICF is a global advisory and technology services provider, but we’re not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future.

We can only solve the world's toughest challenges by building an inclusive workplace that allows everyone to thrive. We are an equal opportunity employer, committed to hiring regardless of any protected characteristic, such as race, ethnicity, national origin, color, sex, gender identity/expression, sexual orientation, religion, age, disability status, or military/veteran status. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO & AA policy.

Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation please email icfcareercenter@icf.com and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.

Read more about workplace discrimination rights, the Pay Transparency Statement, or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act.

 

Pay Range - There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position is:

$92,986.00 - $158,076.00

Nationwide Remote Office (US99)

Non-CA Pay Range (Annual):

$143,600.00 - $266,800.00

At Infinera, your base pay is one part of your total compensation package. Your actual base pay will depend on your skills, qualifications, experience, and location. This role may be eligible for equity grants, discretionary bonuses, or commission payments. The amount of these incentives is based on the terms of the Company’s incentive plans, the Company’s financial performance, and/or individual employee job performance.

Infinera also offers paid leave, medical, 

dental, and vision coverage, 401(k), life, and disability insurance and to

eligible employees.

The R&D Quality Director role requires a unique blend of management and hands-on expertise, serving as a vital bridge between Quality and R&D. We are seeking a seasoned professional with over 20 years of industry experience, including substantial exposure to both software and hardware development. The successful candidate will lead a team of three quality managers, closely partnering with R&D to drive continuous improvements in product quality and processes. This pivotal role ensures that quality remains at the forefront of R&D efforts, fostering excellence across the entire organization.

Key Tasks & Responsibilities:

Secure Quality in Products & R&D Programs

• Q target setting and monitoring
• Process tailoring to secure programs have optimum R&D processes in place and adequately supported and deployed
• Installation & execution of Program Quality Plans and use of metrics for monitoring and analysis of process performance
• Q-Gate readiness check; product quality reviews and audits to monitor and foster process adherence

Support R&D Process Management

• Support process management with subject matter expertise on international Q standards (e.g. TL, ISO) and best practices (e.g. left shifting)
• Support the development, assessment and implementation of key R&D product and process performance measures/metrics

Drive Continual Improvement

• Promote proactive key improvement quality practices
• Support product RCA analysis on field issues escalated to R&D
• Manage process improvement projects that are aligned with strategic goals
• Provide training as it relates to driving process improvements

Value add:

• Independent and neutral Q org to secure quality in products and R&D programs
• Seamless e2e Q workflow supported via Global Quality organization

KPIs:

• Customer-perceived KPIs (CFD, Outages…)
• Q KPIs (test execution rate, test pass rate, critical faults…)
• R&D KPIs (code coverage, defect density, code review effectiveness…)
• TL9K Metrics for certified Product Categories

Key interfaces:

• R&D / ProdM / Service Teams
• Global Q Community

Required Experience:

• 15+ years of experience in SW & HW Development
• Proven Q mgmt. approach with expertise on best in class Q practices & methods
• Experienced leadership re cross-functional / international teams
• Certified auditor
• ISO9K, TL9k, CMMI & Agile
• Jira, SFDC

#LI-DW

#LI-Hybrid

Infinera is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Infinera complies with all applicable state and local laws governing nondiscrimination in employment.

Job Description

***PLEASE SEND YOUR CV IN ENGLISH***

General position summary:  

Associate Director, Regional QA Lead (LATAM & Central America) is a leader within International Quality organization who holds responsibility in ensuring quality compliance in LATAM and Central American Vertex Affiliates. This position holder has an oversight of the distribution network, including distribution partners, and will lead quality oversight initiatives associated with LATAM and Central American region. Associate Director, Regional QA Lead will also ensuring ongoing maintenance of the licenses, leading regulatory inspections, and supporting International Quality in wider regional or global projects.

This Position Reports to: Director, Market Quality

This is a hybrid role based in Sao Paulo, Brazil.

Key Responsibilities:

LATAM & Central American Regional activities:

• In cooperation with International QA teams, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS).
• Provide strategic guidance for and facilitate ongoing maintenance of processes and supporting systems.
• Act as the key liaison with Regional Business Partners in International Supply Chain and Commercial and provide strategic direction and alignment with business needs.
• Identify, assess and communicate mitigation plans for the risks determined within the region.
• Lead regional QMS harmonisation initiatives and support business partners from the QA perspective.
• Support geographical expansion activities to ensure that Quality related actions are planned into projects and completed in line with commitments.
• Oversight and maintenance of the local Drug Establishment Licenses.
• Ensure documented system is in place to support GxP compliance management both internally and externally, with all manufacturers and third parties to whom activities are delegated.
• Maintain oversight of outsourced activities and associated quality technical agreements.
• Ensure close partnership and alignment with other QA teams within Vertex in relation to product launch (process development, alignment on roles & responsibilities etc) in ensuring clear QA representation within regional affiliates.
• Support product recall and mock recall operations for Vertex LATAM and Central American sites.
• Act as the ‘go-to’ QA Subject Matter Expert.
• Maintain QA oversight of Named Patient Supply and Managed Access programs.
• Ensure QA oversight in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
• Build effective relationships with distribution QA in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight.
• Assess the impact and approve deviations, CAPAs and Change Control related to QMS.
• In collaboration with supply chain, ensure that supply chain maps are maintained for all distribution channels.
• Manage internal audits and support external audit scheduling, scope and other qualification activities.
• Perform risk assessments relating to Distribution Partner activities.

Key technical knowledge and skills:

• Strong leadership skills with the ability to lead a team to thrive in a fast paced, evolving environment.
• Able to leverage knowledge of organisational objectives, goals and mission to shape QA initiatives.
• Takes risk-based approaches to create a variety of cost-effective solutions that ensure that compliance and business requirements are optimized.
• Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness.
• Ability to recognize risks and issues impacting the budget, and develop recommendations for mitigation across scope of responsibility 
• Develop and apply creative solutions that meet demands of the function
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
• Work cross-functionally with all levels to foster exceptional collaboration.
• Root Cause Analysis tools/methodology
• Sense of urgency- ability to act quickly/escalation process/transparency
• Attention to detail
• Fluency in verbal and written English and Portuguese. Spanish would be a big plus.

Minimum qualifications:

Master’s degree and relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and significant years of relevant work experience.

Qualifications:

• Degree in pharmacy, chemistry, medicine, biology or a related life science
• GDP & GMP work experience, or relevant comparable background.
• Experienced Lead Auditor
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Company Information

The Deputy DIPC will work with the Director for Infection Prevention and Control (DIPC) to lead, manage and provide a proactive strategic infection prevention and control service ensuring that the Trust continually improves its performance in reducing healthcare-associated infections by developing systems that are evidence-based and grounded in best practice. As a professional role model and strong clinical leader you will demonstrate an excellent understanding of infection prevention and control issues, analytical thinking and ensuring that patients are placed at the centre of care delivery.

Our Infection Prevention and Control (IPC) team is recognised for its expertise and ability to support clinical and corporate services, which continues to be vital to the delivery of safe services. Due to internal promotion we are looking for a new Deputy Director for Infection Prevention and Control to join and lead the team.
• Working in conjunction with the Director of Infection Prevention and Control (DIPC), the Deputy Director of Infection Prevention Control (DDIPC) has a strategic leadership and management responsibility for the ongoing development and sustainability of a high quality and innovative infection prevention and control service for the Trust.
• The DDIPC is operationally responsible for the delivery of the Trust Infection Prevention and Control (IPC) service, working in conjunction with the DIPC, senior members of the IPC team, as well as senior divisional and corporate colleagues across the Trust.
• The DDIPC, working within the wider team, will have significant Trust wide responsibility and will be accountable for the strategic and operational management of the IPC service.
• The post holder will have significant Trust wide responsibility with respect to developing, leading and directing the Trust’s programme to reduce healthcare-associated infections as established in national trajectories and locally as established.
• The post holder will undertake a full portfolio of responsibilities as agreed and delegated by the DIPC and will be responsible and accountable for providing comprehensive and strong professional leadership, guidance advice, support and direction in relation to infection prevention and control, antimicrobial stewardship

At Imperial College Healthcare you can achieve extraordinary things with extraordinary people, working with leading clinicians pushing boundaries in patient care. Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You’ll get an experience like no other and will fast forward your career.

Benefits include career development, flexible working and wellbeing, staff recognition scheme. Make use of optional benefits including Cycle to work, car lease schemes, season ticket loan or membership options for onsite leisure facilities.

We are committed to equal opportunities and improving the working lives of our staff and will consider applications to work flexibly, part-time or job share.



The full job description provides an overview of the key tasks and responsibilities of the role and the person specification outlines the qualifications, skills, experience and knowledge required. For both overviews please view the Job Description attachment with the job advert.


This advert closes on Monday 1 Apr 2024

The full job description provides an overview of the key tasks and responsibilities of the role and the person specification outlines the qualifications, skills, experience and knowledge required. For both overviews please view the Job Description attachment with the job advert.

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

Our search for better is changing the lives of our customers. It’s changing the careers of our people too –creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as a Senior Director, Quality (Complaint Handling and Post Market Surveillance), and you won’t either.

 

This is a key role within the Global Quality function, driving a high-performance culture and setting the standard for Quality Excellence. We are seeking a transformative thinker and diligent executor to help improve the operational execution of Complaints & Post Market Surveillance.

The Senior Director, Quality (Complaint Handling/PMS) will be accountable for the global complaint handling and post market surveillance process for the entire business, inclusive of all business units.  You will partner with the business for timely execution of complaint investigations to enable robust feedback from our customers.  You will develop and lead a team that reviews, processes and analyzes complaints data into practical business terms to ensure proper prioritization of initiatives to improve the customer experience and deliver on our forever caring promise.  This strategic partner will collaborate with the commercial organization to ensure all channels for reporting complaints are efficient and integrated, providing them with real-time complaints progress & feedback. 

Your Accountabilities and Responsibilities:

• Define global strategy for complaint handling and post market surveillance across Convatec. 
• Turn complex complaints data/information into practical analytics to facilitate business decisions. 
• Lead, mentor, coach, and develop complaint handling and post market surveillance teams.
• Partner with business unit (BU) leaders with an emphasis in manufacturing site collaboration in BU specific complaint analysis, ensuring the right focus/actions are placed in the main areas of opportunity/concern.
• Establish clear roles & responsibilities when liaising with legal, medical, quality, regulatory, operations, engineering, and other functions in the complaint handling and post market surveillance processes.
• Own  dashboard of performance related to complaint handling and post market surveillance activities.
• Develop strategy that drives improvements in the customer experience and facilitates how customer complaints are collected throughout the world.
• Harmonize & connects global processes for efficiency.
• Define strategy with commercial on how we gather & analyze feedback from social platforms and other media streams.
• Acts as the main point of contact for complaint handling - including complaint processing, investigation, and timely closure.
• Integrate data analytics into established power BI dashboards to enable one source of truth.
• Partner with R&D (Technology & Innovation) to ensure design related complaints have a clear funnel for investigations. 
• Integrate technology into repetitive tasks, to optimize speed of processing and focus on clarity of analytics for signals & corresponding actions.
• Drive continuous improvement in corresponding processes & tools.
• Identify, hire, train, develop and maintain qualified Quality personnel to support the Quality plans, objectives and goals.

 

The Ideal Candidate should bring the following qualities to the role:

• Minimum of B.S., or equivalent, in a scientific/technical discipline is required.  Advanced degree (M.S., M.B.A, Ph.D. or equivalent) preferred.
• Experience working in an international environment in a global position is required.
• Certifications in Quality Management Systems preferred.
• (5-7) years in the medical device and/or pharmaceutical industry.
• Five to seven (5-7) years’ experience in a leadership role.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Outstanding communication skills (both written and spoken), to all layers of the organization, including executive level.
• Emotional Intelligence/cultural awareness (interacting globally).
• Ability to think in a clear, decisive manner, remaining calm under stressful and challenging conditions.
• Ability to efficiently work through quality, organization and business issues with a focus on solutions and proactive contingency planning in support of the customer and business objectives.
• Ability to apply budgetary analysis principles and effective allocation of internal/external resources.
• Strong understanding of risk management principles and ability to apply these principles in day-to-day quality management activities, compliance issues, and business challenges.
• Commercially astute and customer focused.

Working Conditions:

• Fulltime position

Travel:

• Role is remote-based with preference to location in the United Kingdom
• Travel is expected to be approximately 25% with projected international travel

Language Skills Required:

• Speaking: English
• Writing/Reading:  English

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen too.  It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll move you.

#ForeverCaring #ForeverConvatec #WeAreConvatec

#LI-DB1

#LI-REMOTE

 

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!

 

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Associate Director of Quality Systems ensures that the GMP systems and controls in place at the site meet Global Quality Standards and applicable regulatory requirements.  S/he liaises with Global Quality leadership and is a conduit for driving harmonization and alignment within the biologics network.  Additionally responsible for ensuring that significant quality concerns are documented within the Quality Management System (QMS) and for maintaining systems that prompt the appropriate mitigation/remediation actions. 

This position typically has oversight of direct reports and will assign resources and priorities, ensure adequate training, coaches and develops staff, evaluates performance, and supports overflow of tasks across Quality as needed.  The Director of Quality Systems is a member of the Senior Quality organization and participates in decision making for escalations and communication of decisions at the site.

Key Responsibilities:

• Partners with the Site Quality Head and Global Quality leadership to propose approaches in executing the strategic quality goals and ensuring alignment across the network.
• Oversees the hiring process for Quality Systems personnel, provides performance feedback, coaches, mentors and supports career development.
• Sets and communicates direction for Quality Systems teams that is current with industry trends, guidelines and regulations.  Responsible to ensure progress and completion of opportunities and continuous improvement initiatives.
• Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance in resolving issues.
• Participates in the hiring process, provides performance feedback, coaches, mentors and supports career development.
• Designs and implements Quality System improvements while ensuring high level internal / external customer support.
• Acts as a point of escalation for QA staff and customers.
• Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings. 
• Attends Site Quality Council and Lot Disposition meetings.
• Provides TrackWise Quality System site administration, i.e. maintain personnel records, site user accounts, provide user support/ helpdesk/ troubleshooting.
• Manages and tracks Key Performance Indicating Quality Metrics including compilation of monthly/quarterly deviation trending reports for site management.
• Owner of Site Quality Council meeting.
• Product Quality Review (PQR) administration.
• Supports Customer audits and/or Regulatory inspections.
• Performs other duties as assigned, including reviewing and approving various documents (e.g. Product Quality Reports, Quality Agreements, Deviation Reports, filing reviews) and lot disposition.

Key Qualifications:

• Demonstrated ability to present ideas publicly to inform, educate and influence others positively in achieving business results
• Mentoring and leading direct reports
• Being able to deliver difficult messages to staff (i.e. disciplinary actions, poor performance plans)
• Use of Microsoft Suites (Word, Excel, PowerPoint)
• Advanced use of Enterprise GMP Quality Systems such as: TrackWise, DMS LIMS, ELN (iLAB), MODA, CDS (Empower)
• Able to interpret data
• Perform assigned, complex, and/or varied tasks
• Prioritization and problem solving
• Direct, control, and plan tasks/projects
• Excellent communications skills both written and verbal format
• Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff
• Maintain positive attitude and emotional composure in a team environment
• Timeliness in completing assigned tasks
• Makes quality decisions independently and also with guidance from Site Quality Head

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.  

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. 

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.  

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be tasked with the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. They will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Primary Duties:

Operational Quality Management:

• Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. 

• Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT. 

• Collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.

• Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).

• Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.

• In partnership with the CQOL, the CQOM will develop skill sets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).

• Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.

• In collaboration with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.

Inspection Preparation and Management:

• Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.

• Lead and support GCP inspections, worldwide.  The CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.

• Team up with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.

• Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).

• Contribute to the development and/ or revision of our Company policies, SOPs and training materials.

• Develop the strategy for management/support for GCP inspections of our Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.

• Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.

• In partnership with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.

• Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.

• Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.

• Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.

CAPA Management Support:

• Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner.  Track all inspection CAPA and regulatory commitments and checks evidence of completion.

• Ensure repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.

• Provide guidance and support for CCQMs regarding inspections at a country level sites that require a company headquarters input.

Other activities:

• Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.

• Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.

• Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.

Education: 

• Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.

Experience:

• Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.

• Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.

• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.

• Experience with delivering effective CAPA management solutions.

• Experience with risk management tools and processes within the clinical quality framework.

Skills: 

• Superior oral and written communication skills in an international environment.

• Ability to manage and develop others, including formal performance management when required.

• Excellent project management and organizational skills.

• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.

• Lead cross-functional teams of business professionals within and outside our Research Division.

• Act urgently for worldwide health authority inspection matters.

• Analyze, interpret and solve complex problems.

• Think strategically and objectively and with creativity and innovation.

• Effectively interact with all levels of specialists & management and exert influence to achieve results.

• Identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned. 

#EligibleforERP

MRLGCTO

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

Click here to request this role’s pay range.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$135,500.00 - $213,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

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GENERAL FUNCTION:

Responsible for the continued development and implementation of the Bancorp's compliance programs and management of the related Compliance Managers and teams, including ensuring compliance with Federal laws and regulations and industry standards. This position is responsible for providing strategic leadership / direction / oversight regarding the Bancorp's compliance risk management programs, including policies, testing, reporting, and control framework. The incumbent is responsible for analyzing current and emerging regulatory trends and proposing and implementing recommendations or system solutions to mitigate identified risk. This position is also responsible for team member development and employee engagement.

Responsible and accountable for risk by openly exchanging ideas and opinions, elevating concerns, and personally following policies and procedures as defined. Accountable for always doing the right thing for customers and colleagues, and ensures that actions and behaviors drive a positive customer experience. While operating within the Bank's risk appetite, achieves results by consistently identifying, assessing, managing, monitoring, and reporting risks of all types.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Direct, Develop and Oversee the strategic aspects of the compliance programs. this includes overseeing policies and procedures, testing programs, and the employee Education programs for the Bancorp.
• Responsible for the management, direction and oversight of Federal laws and regulations.
• Oversee / Direct the execution of the Bancorp compliance risk Assessment for the compliance programs.
• Serve as a key contact with bank regulators for compliance exams (develop and maintain relationships, facilitate discussions, demonstrate strategic leadership regarding the program and future initiatives).
• Provide periodic Reports to senior management and board Committees on industry trends, state of the compliance programs and the status of Key initiatives.
• Develop and maintain relationships between compliance risk management and associated line of business leaders to ensure the implementation of effective compliance programs across the Bancorp and related Lines of business. Actively promote a solution-oriented environment throughout the department.
• Provide compliance subject matter expertise and sponsorship for Lines of business and Bancorp projects, processes, and products.
• Work with Lines of business compliance managers and officers to identify policy and procedural enhancements. in reference to new products and new initiatives work with the teams to ensure proper Assessment of the risk, the planning of Controls and the adequate execution of those controls.
• Maintain networks with industry working groups that are dedicated to bank compliance to benchmark and share best practices.
• Provide leadership, motivation, coaching and Assessment to ensure optimum team and individual performance in Support of department, division and Bancorp goals.
• Maintain a cutting edge awareness of company goals, Regulatory and legislative developments, and industry trends.
• Leads and directs the analysis of policies and procedures, including scoring systems, strategic priorities, market share data, trends, external influences, current regulatory focuses, previous examination findings, and input from Audit and Legal.
• Conducts interviews and discussions with senior level managers to Understand process, guidelines and Technology platforms.
• Analyzes data by numerous delivery channels, geographic area, product types, facility, and even employee or officer to identify risks and Develop and recommend scope or target for the Review, corrective action/or performance gap closure. Develops and executes strategies for closing gaps in performance.
• Assess the adequacy of the business units'/affiliate's recommended corrective action to the issues or gaps identified.
• Develops and reports findings to Senior Management regarding their business lines (Legal, Audit, and Senior level Operating Committees).
• Works closely with Sr. leadership to Set strategic direction for department and executes on those goals and objectives.
• Participates and/or Leads regular meetings with peers to Build and maintain knowledge of current and emerging issues and risk in the environment.
• Reviewing and approving recommended solutions for the Regulatory Monitoring and Change management Program ownership.
• Review and address concerns from compliance testing results.
• Contribute updates to the compliance risk assessment.
• Support post-implementation validation based on risk rating.
• Reviews reporting from the Councils for use by the Regulatory Change management Committee.
• Areas of responsibility and accountability within compliance Include: consumer, commercial, Wealth & asset management, testing & practices, financial Crimes and all other relevant and applicable laws and regulations

SUPERVISORY RESPONSIBILITIES:

Manage staffing of the Compliance teams to ensure optimal performance in meeting the Risk Management Division's goals and objectives by providing employees timely, candid and constructive performance feedback; developing employees to their fullest potential and providing challenging opportunities that enhance employee career growth; developing the appropriate talent pool to ensure adequate bench strength and succession planning; recognizing and rewarding employees for accomplishments.

Senior Compliance Director

LOCATION -- Charlotte, North Carolina 28202

Fifth Third Bank, National Association is proud to have an engaged and inclusive culture and to promote and ensure equal employment opportunity in all employment decisions regardless of race, color, gender, national origin, religion, age, disability, sexual orientation, gender identity, military status, veteran status or any other legally protected status.