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

Job Overview:
This position is for an Associate Quality Assurance Director in the Risk Analytics team who will serve as the strategic quality engagement leader focusing on risk analysis projects and tracking for each business function with primary focus on Clinical Operations. The role includes the following activities:

Responsibilities:

• Predominantly supports Clinical Operations globally.

• Provides actionable insights from risk analysis and operational data analysis and working with cross-functional stakeholder to develop action plans to drive continuous improvement.
• Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams
• Supports the management and resolution of significant issues relating to quality.
• In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
• Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
• Contributes to the development of the global risk-based internal audit plan.
• Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
• Prepares for and actively participates in relevant Governance/partnership level meetings e.g., Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
• Interfaces with senior management to discuss quality and compliance issues
• Interfaces with business development and operations to identify business opportunities
• Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.
 

Qualifications
• Bachelor's Degree  Mandatory
• 8-10 years experience Quality Assurance experience preferably within a CRO space or related area that includes GCP Quality Assurance experience.
• Knowledge of Excel, spreadsheet, and eQMS platforms (SmartSolve is preferred).
• Strong knowledge of GCP quality standards.
• Considerable knowledge of quality assurance processes and procedures'.
• Strong interpersonal skills and the ability to positively influence and guide others.
• Excellent problem solving and risk/data analysis skills.
• Effective organization, communication, and team orientation skills.
• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
• Demonstrated ability to lead and manage multiple responsibilities.
• Identify functional constraints and identify solutions.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Job Description

General Summary:

The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams.

**In this a 2nd, shift, On-Site designated role. ou will work five days per week on-site with ad hoc flexibility.**

Key Duties and Responsibilities:

• Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex
• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
• Enable team to achieve team goals/objectives and enable their individual career development
• Develop and maintain compliant quality processes to support GMP activities
• Oversee the QA support of Change Controls, GMP investigations (deviations) and associated CAPAs.
• Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes
• Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.
• Support review of regulatory submissions, as applicable
• Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
• Lead and follow up on any QLT action items assigned.
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs; assists in preparation of audit responses
• Provide comprehensive knowledge support for partner and regulatory agency audits
• Assist management team in budgeting and scheduling
• Responsible for the following activities related to people management responsibilities:
• Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding
• Performance Management (goals, monitoring, reviews);
• Monitoring /Supporting Employee Engagement and Retention;
• Succession Planning;
• Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs.
• Accountable to provide oversight of day to day team operations
• Assists with workforce planning/resource modeling and to update through forecasting activities

Knowledge and Skills:

• In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a biotech setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing
• Demonstrated success in building high-performing teams and skilled at managing team and individual development
• Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness
• Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
• Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit
• Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development
• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action
• Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions
• Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
• Experience with electronic document management systems desirable (e.g., Trackwise, Veeva)

Education and Experience:

• Bachelor's degree in a scientific or a allied health or equivalent degree
• Typically requires 8 years of work experience and 4 years of management experience, or the equivalent combination of education and experience

On-Site Roles

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite #LI-AR1

Company Information

Job Description

A wonderful opportunity has arisen to join the Ballydine site as Associate Director Quality Assurance. Reporting to the Quality Director, the incumbent will work with the Quality Leadership team to ensure compliance with all regulatory requirements for Drug Substance (DS), Spray Dried Intermediate (SDI) and Drug product (DP) released to downstream customer. This is a permanent role with opportunities for some home working.

Role Responsibilities 

• Provide Quality support to the Integrated Process Teams (IPT) to ensure the facility meets and operates to all Good Manufacturing Practice (GMP) requirements for development, clinical and commercial supply.
• Participate as a team member in the Documentation Review and Approval Process, Deviation Management Process, Quality Risk Management, Change Control Management and New Product Introduction.
• Support internal, customer and regulatory GMP audits of the plant.  Act as lead auditor for internal walkdowns and systems audits to ensure compliance with cGMPs to maintain inspection readiness.
• Accountable for the development and performance of the team, providing input and coaching on professional development. Provide timely feedback and ensure that responsibilities are delivered following appropriate inclusion principles & behaviours.
• Lead and support Continuous Improvement of Quality and site processes.
   

Qualification Requirements  

• Degree or post graduate qualification in Science, Pharmaceutical or Engineering field.
• Minimum of 5-year experience in the Pharma regulated industry with leadership experience. Clinical and commercial GMP experience preferred. 
• Excellent knowledge of regulations and sources of regulatory information.
• Experience with regulatory inspections.
• Qualified Person qualification is an advantage.
• Experience in High Potency Manufacturing, Continuous Manufacturing, Spray Drying, Laboratory GMP and Project Management is desirable.
• Demonstrated continuous improvement mindset and capabilities. 
• Dynamic individual with excellent organizational skills, who can effectively collaborate with cross functional teams.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

N/A

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

about the company
Our client is a life insurer based in Singapore. They are now looking for a Director, Global Financial Crime Compliance to be responsible for leading the financial crimes compliance function for the group. This role will cover global markets.

about the job
You will be responsible for ensuring that the organisation complies with all relevant laws, regulations, and policies related to financial crimes on a global scale. You will work closely with various internal teams to develop, implement, and maintain effective compliance programs and controls to mitigate the risk of financial crimes, including money laundering, economic sanctions, fraud, and corruption.

about the manager/team
This is an individual contributor role, reporting to the Group Chief Compliance Officer.

skills and experience required

• Certified AML Specialist or similar qualification is ideal
• Minimum Bachelor's Degree
• Regional/global experience in financial crimes compliance in the financial services sector. Insurance experience will be a plus.

To apply online please use the 'apply' function

Job Description

A fantastic opportunity has arisen for a QC Systems Associate Director, this is a key site leadership position within the QC department, where you will be responsible for providing vision, leadership and direction for the QC Systems team.

This position carries the remit and accountability to enable the site to bring the very best of innovation to the oncology patients of the world who are counting on us to deliver.The role ensures that the QC team objectives are effectively achieved, consistent with our company's requirements to ensure compliance, safety and reliable supply to our customers. The successful candidate will bring energy, knowledge, leadership, and innovation to carry out the following:

What you will do:

• Creates a diverse and inclusive culture that excels in safety, quality and delivers on the strategic vision for Biotech Dublin QC as a paperless tech enabled Laboratory.
• Supports the QC Laboratory through QC Systems and equipment installation, qualification, operation, and retirement.
• Leads continuous improvement of QC operations, through their QC Systems knowledge and areas of expertise.
• Purchase, install, qualify, build, maintain, and integrate QC Systems, as required, including divisional systems, instrumentation, and their software or equipment, in compliance with up-to-date data integrity, regulatory, and industry standards.
• Author, review and approve technical documents, standard operating procedures, deviations, investigations, change management related to QC Systems.
• Lead project management to meet established QC Systems delivery timelines.
• Oversight and management of the Stability Program at the site.
• Implementing stability strategies for new and licensed products and ensuring oversight of execution of stability protocols as per the overall stability strategy.
• Work cross-functionally with our company's internal sites and global partners to successfully implement Technology Enabled Labs (TEL) capability within the QC department
• Define and lead the change management process and mechanisms required to maintain QC Systems in a validated state throughout their lifecycle.
• Troubleshoot divisional systems, instrumentation and their associated software or equipment as subject matter expert (SME).
• Lead, coach and mentor the QC Systems team. Build diverse talent with the capabilities necessary to succeed in commercial drug substance manufacture. Develop team members through supporting their continued personal and professional career growth.
• Assisting in and facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs.
• Represent the QC department as a QC Systems SME for internal audits/regulatory inspections and support permanent inspection readiness.
• Escalate potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality.
• Inspire Diversity and Inclusion by building effective working relationship with cross-functional teams across different cultures and backgrounds.
• Drive and own metrics that appropriately and accurately measure QC performance and take action to mitigate as required.
• Support various site functional and cross functional tier structures.

• Be an advocate for continuous improvement, new technologies and innovation. Lead and foster an environment of continuous improvement through deployment of Model Lab and management systems across the lab operations.
• Trouble-shoot laboratory process and equipment issues as needed.
• Actively participate in Site/Quality committees and works with other site functional groups to help set direction for GMP and continuous improvement initiatives.

What skills you will need:

To excel in this role, you will more than likely have:

• Degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline, the successful candidate will also have significant exposure in delivering operational excellence in GMP environment
• This role requires a seasoned professional with the expertise (10 to 15 years) with at least 5 years in a leading position and attributes that will ensure success in this highly accountable role.
• Working knowledge in the biotech industry is required with specific understanding of QC operations, regulatory agency engagement and ability to gain alignment on strategy.
• The successful candidate should have the knowledge and ability to mentor the QC systems implemented at the site.
• Strong stakeholder management skills and proven experience dealing with above site groups, particularly for divisional systems
• Demonstrated ability to manage multiple priorities against ambitious timelines.
• Strong problem-solving skills and ability to work cross-functionally as critical member of site team
• Hands-on application of lean tools and techniques: standardized work, scientific problem solving, value stream mapping, capacity analysis.
• Coaching, teaching, and driving a High-Performance Organization. Proven experience in coaching and teaching others to think, behave and apply lean methods and tools. Experience enabling and leveraging diverse perspectives, talents, etc. to achieve business outcomes.

As a company, we are dedicated to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are dedicated to flexible working where possible, and therefore our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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 are able to adapt to a changing regulatory landscape.

YOUR IMPACT

In Federation Compliance in Singapore, you will cover the Federation in Singapore, Hong Kong, China and other Asia Pacific markets. You will also participate in region-wide and global initiatives to enact the Global Compliance mandate. To fulfill this role and responsibilities, you will be:

• Conducting risk identification, measurement and assessment
• Monitoring for compliance with laws, rules, regulations and policies
• Participating in firm responses to regulatory examinations, audits and inquiries
• Performing surveillance and investigations of business activities
• Testing the effectiveness of controls
• Writing policies and procedures
• Communicating regulatory requirements and firm policy expectations to educate others

HOW YOU WILL FULFILL YOUR POTENTIAL

Federation Compliance provides compliance coverage to the Operations, Technology, Finance, Risk, Services and Human Capital Management divisions (“the Federation”). This includes:

• Advise, challenge and influence the Federation about regulations, policies and reputational risk
• Identify, investigate and manage compliance issues involving the Federation
• Analyze regulatory changes and enforcement actions to assess the impact to the Federation, and participate in work to ensure the business is able to support new requirements
• Review surveillance alerts and conduct forensic reviews to monitor the Federation’s compliance with regulations and firm policies
• Recommend compliance testing work to be performed for the Federation
• Draft and assist in the implementation of policies and procedures
• Develop and deliver communication and training to the Federation

Basic Qualifications

A strong candidate for Federation Compliance will satisfy the following criteria:

• Bachelor’s degree; advanced degree in relevant field (e.g., J.D., LL.M., M.B.A.) is a plus but not required
• At least 5-7 years of work experience, including 3 years as a compliance officer or in a risk management role focused on regulatory requirements
• Knowledge of operational practices in securities and derivatives markets
• Knowledge of regulations, practices and markets infrastructure
• Experience working as a regulator, interacting with regulators, or supporting regulatory audits or inquiries

A strong candidate for Federation Compliance will possess the following skills:

• Clear, concise communications skills; able to communicate with impact at senior levels
• Able and willing to challenge; comfortable with inter-personal conflict; able to build strong professional rapport with stakeholders while maintaining independence as a risk manager
• Sound judgment, ethics and integrity
• Fast learner; able to adapt to business and regulatory changes; interest to challenge status quo and find new solutions
• Proficient in using technology; able to analyze data sets and summarize findings; comfortable learning new technologies, both as a user and to identify risks
• Team-oriented and supportive of others’ success; comfortable representing a team work product to stakeholders

Job Description

Support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. Utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.

This position is responsible for the execution of the global Quality Assurance audit activities on assigned studies, products, vendors and Country Offices. This role is accountable for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures, policies, and all applicable worldwide regulations and guidelines.

Primary activities include, but are not limited to:

• Prepares and conducts Quality Assurance (QA) audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g., Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable;
• Activities may include Good Clinical Practice (GCP) and Pharmacovigilance (PV) routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third-party collaborations and due diligence activities; 
• Will represent QA as a single point of contact and provides QA guidance for studies;
• Serves as a member of the project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls;
• Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise;
• Proactively identifies, analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies;
• In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate;
• Actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements);
• Analyze and leverage quality indicators and data to identify potential trends and risks and perform root cause analyses to enable principles of knowledge-based auditing;
• Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions. Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the Quality Assurandce Lead and Therapeutic Area Head;
• Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies;
• Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally;
• Provide inspection management support as appropriate;
• Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards;
• Promotes standardization of auditing approach within QA;
• Routinely suggests new audit techniques/aids in areas of technical expertise;
• Design and actively participate in special assignments on various project teams and work streams as determined by QA management.

Main requirements:

• Bachelor's degree or higher (or equivalent qualifications) in pharmacy or a life-science subject;
• Broad and in-depth knowledge of the drug development process, Good Clinical Practice guidelines, and applicable regulations is essential;
• Experience as a clinical quality professional is required;
• Experience as a clinical quality auditor will be considered a plus;
• Business Acumen and Attention to Detail.
• Logic and analytical skills using rigorous logic and methods to solve difficult problems with effective solutions;
• Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats;
• Creative Thinking engaging new ideas or ways of doing things and influences creative thinking;

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 

Current Employees apply HERE

Current Contingent Workers apply 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Calling all passionate quality leaders! Join us as Associate Director & Qualified Person and make a significant impact on the success of our global clinical supply chain! 

This pivotal role lets you build and lead a team, ensuring the flawless delivery of life-changing medicines worldwide. 

Join us and make a real difference in patient lives.

Purpose of the position

In this crucial role, you'll directly support the Director, GDQ (Global Development Quality), by ensuring the smooth operation of our global clinical supply chain. You'll achieve this by overseeing all activities related to the disposition of clinical finished goods used in our worldwide trials. This includes building a dedicated team of two Senior QA Specialists at our Haarlem site.

Your primary focus will be ensuring the quality and compliance of investigational medicinal products (IMPs) throughout our Global Clinical Supply (GCS) Warehouse and Distribution network. You'll achieve this by overseeing all quality assurance activities related to Good Manufacturing Practice (GMP) compliance for the IMP license. Additionally, you'll design and manage a robust Quality Management System (QMS) for the clinical supply warehouse and distribution functions.

To maintain a seamless global clinical supply chain, you'll manage the distribution, and final disposition of clinical finished goods. This collaborative role will require you to work closely with internal and external partners to guarantee the on-time delivery of cGMP-compliant clinical supplies worldwide. You'll also be the company's voice during regulatory inspections pertaining to the IMP license and QMS.

Welcome to our team

The Global Development Quality (GDQ) organization is responsible for providing quality oversight of internal clinical packaging and distribution operations and supply chain management support for the end-to-end clinical supply chain.

Our team partners broadly across our company and our external partners to deliver continuous current good manufacturing practices (cGMP)-compliant clinical supply on time, every time, across the globe.

Primary responsibilities 

• Act as Quality site lead / QP for quality aspects of warehousing and distribution activities at the site in Haarlem. 

• Provide QP certification of batches of IMPs packaged for Clinical Trial use as required by directive 2001/20/EC.  

• Drive the implementation of the quality strategy at site.  

• Oversee the recruitment, management and development of the Quality team.

• Lead the departmental and site preparation for internal and external audits

• Champion the continuous improvement of the quality strategy by prioritizing, initiating and monitoring related improvements. 

• Legally responsible for the executions of releases and the execution of potential recalls. 

Your profile

• Master's degree in science or Pharmacy qualification (QP eligible).

• 6-8 years in pharma Quality Assurance, ideally with manufacturing & logistics experience. 

• Several years of experience as a Qualified Person (QP).

• Strong team leadership & coaching skills.

• Proven ability to analyze, recommend & lead quality initiatives.

• Excellent communication with strong analytical thinking and EU GMP/cGMP knowledge.

• Fluency in English (written & spoken)

• Travel willingness (up to 10%)

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end bonus;

• 35,5 days of leave;

• Attractive collective health care insurance package with considerable reduction rates;

• Solid Pension Plan;

• Incentive Plan;

• Travel allowance for commuting;

• On-site sports facilities

• Numerous training, coaching and e-learning modules for long term job opportunities and development

Current Employees apply HERE

Current Contingent Workers apply 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

About the Role

Looking for a driven Associate Director for our Healthcare domain. You will drive the lifecycle of cybersecurity policies, standards, guidelines, and control libraries. Your role involves developing and adjusting cybersecurity policies, enhancing cybersecurity maturity, and ensuring effective stakeholder management, active listening, and alignment with business and policy requirements. Your expertise in continuous improvement, governance, risk management, and compliance will be pivotal in this position. You will be reporting to the Director.

Job Description

• Be the integrator and main point of contact for the development and maintenance of cybersecurity policies, standards, guidelines, and control libraries, fostering collaboration across stakeholders in the public healthcare sector.
• Represent the team from a sectoral cybersecurity perspective, evaluating stakeholders' requirements, expectations, and interactions.
• Drive alignment with stakeholders, including CIOs, CISOs, and other functional leaders.
• Facilitate the rollout of campaigns on policies, risk management frameworks, and assessment methodologies.
• Lead the cybersecurity policies adherence program and innovate to instill a culture of cyber risk awareness in decision-making.
• Proactively evaluate evolving risk trends, posture, and the changing threat landscape to ensure policies, standards, guidelines, and control libraries remain relevant.
• Own the development and continuous improvement of the cybersecurity policies socialisation campaign.
• Evaluate emerging technologies, trends, and regulatory changes.
• Maintain effective relationships with peers, stakeholders, and regulators, integrating policy adherence into the sector's overall strategic objectives.
• Demonstrate domain expertise, fostering continuous learning by creating content, presenting, and supporting a culture of learning.
• Responsible for any other ad hoc duties assigned.

Requirements

• Bachelor in Computer Science /Information Technology or relevant field.
• Recognised industry-leading certifications in relevant areas such as CISM, CRISC, CISSP, and GIAC certifications.
• Experience in policy, standard, and guideline implementation in the cybersecurity and technology risk domain.
• Solid technical writing skills with attention to detail.
• Working knowledge of recognised frameworks and standards such as IM8, NIST CSF, COBIT5/2019, and ISO27000 series.
• Command a good understanding and experience in cybersecurity, risk management, and compliance concepts and processes.
• Ability to consult and influence stakeholders on alignment of outcomes and desired technical solutions.
• Analytical skills to analyse, design, and develop a solution roadmap and implementation plan based upon a current vs. future state.
• Working knowledge of balancing security and business needs.
• Knowledgeable about the full range of services within a cybersecurity function and able to discuss overall solutions.
• Experience sustaining operational stability through various life cycle phases.
• Able to lead early-stage customer interactions on cybersecurity design.
• Adept at navigating the organisational matrix, understanding people's roles, anticipating obstacles, and identifying workarounds.
• Understand how internal and external business models work, facilitating active customer engagement.
• Articulate the value of what is most important to stakeholders to achieve desired outcomes.
• Produce functional area information in sufficient detail for cross-functional teams using presentation and storytelling concepts.
• Possess extensive knowledge of cybersecurity services in the portfolio and proficiency in discussing each area.
• Demonstrate working knowledge of a large organization and cross-functional teams.
• Proven Change Management capabilities.
• Anticipate obstacles, identify workarounds, leverage resources, and rally teammates.
• Strong interpersonal skills, including creativity and curiosity, with the ability to effectively communicate and influence across all organisational levels.
• Proven analytical and problem resolution skills, along with the ability to influence and build consensus with other stakeholders.

About the Company

Our client offers the benefits of a work environment that is stable and cohesive. You will enjoy working with up-to-date technology, and opportunity for growth with ATTRACTIVE BONUS.

Interest & Apply

Interested applicants, please send your resume to jsalim@morganmckinley.com with your current resume and expected salary for a confidential discussion.

EA Personnel Name: Janice Meidalina Salim

EA Personnel Registration No.: R23118765

EA License No.: 11C5502

Job Description:

Baptist Health is looking for a Regional Director, Compliance and Privacy - East to join our team. This is a remote position that requires residency in KY, IN, or IL

Directs and monitors physician practice-related compliance activities on a daily basis which may include more than 50 physical locations and/or more than 200 physicians and non-physician practitioners as well as their support staff, including practice acquisitions in the assigned region.  Contributes to the fulfillment of the mission and vision by planning, designing, implementing and maintaining professional practice programs, policies and procedures.  Assists in the implementation of system-wide and professional practice policies and procedures, develops and conducts educational programs and administers reviews related to the Baptist Health HIPAA Privacy Program.  Oversees all ongoing regional activities related to the development, implementation, maintenance of and adherence to the Baptist Health policies and procedures covering the privacy of, and access to Protected Health Information (PHI) in compliance with federal and state laws and BHS policies and procedures.

Responsible for the due diligence on compliance-related issues and determines the appropriate corrective action, to include the identification of operational gaps, process improvement needs, identification of educational opportunities and coordinating resolution.  Communicates findings and recommendations to the BHMG regional leadership team and facilitates effective resolutions in a timely manner.

This position requires frequent travel within assigned region (up to 60%).  Travel expenses may be reimbursable according to the Baptist Health Travel policy. 

Minimum Requirements

• A bachelor’s degree with a minimum of five years of experience in physician practice operations, compliance, medical billing, or related area is required. 

• Minimum of three years of management experience in physician practice operations, compliance, or other related area is required.  (A minimum of five years' work experience which demonstrates strong leadership may be considered in lieu of management experience.)

• Demonstrated leadership skills with strong commitment to assume responsibility and effectively collaborate across all levels of an organization.

• Physician Coding Certification (by AHIMA and/or AAPC) and/or Certification in Compliance (HCCA or AAPC) and experience in physician procedural and diagnosis coding, third party payer reimbursement, and CMS requirements specific to Medicare Part B preferred.

• Exceptional organizational and time management skills and the ability to maintain strict confidentiality at all times is required.

If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now!

Baptist Health is an Equal Employment Opportunity employer.

• Develop and direct a privacy compliance program for the university.

• Serve as the university's GDPR data protection officer and oversight for FERPA and HIPAA compliance, partnering with the university registrar on FERPA and the associate general counsel on HIPAA.

• Additionally, serving as the university's HIPAA privacy officer and HIPAA security officer.

• Collaborate with the chief information security officer to ensure alignment between security and privacy compliance programs, including policies, practices, and investigations.

• Ensure that appropriate privacy and confidentiality authorization forms, consents, notices of privacy practices, and other materials reflect current university practices and are consistent with legal requirements.

• Coordinate with university departments and units to ensure proper implementation of all privacy-related audit and investigation recommendations.

• Conduct privacy risk assessments and ongoing privacy compliance monitoring activities in coordination with the university’s compliance and risk functions.

• Review and contribute to policies, procedures, and related processes to ensure the integrity of electronic Protected Health Information (ePHI) and help prevent, detect, contain, and correct breaches of ePHI while enforcing the HIPAA Privacy Rule and the HIPAA Security Rule across all university healthcare components. 

• Develop privacy training materials and other communications to train employees on university privacy policies, data handling practices and procedures.

• Serve on the security incident response team, respond to incidents involving potential or actual exposure or disclosure of restricted data or confidential information, and conduct privacy investigations. 

• In coordination with the office of general counsel, review contract language involving the collection, protection, transfer and/or use of regulated data, and offer guidance on ways to minimize privacy compliance risks.

• Provide highly specialized expertise to leadership on privacy and information protection; related state, federal, and international regulations and laws (including GDPR and FERPA); and industry standards.  

• Additionally, lead or participate on privacy-related university committees and perform other duties as assigned.

Department

Work Schedule

Type of Appointment

Expected Salary

Job Posting End Date

Equal Employment Opportunity Statement:

The University of Central Florida is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets.  Click on UCF's Equal Opportunity Statement to view the President’s Statement.

The UCF affirmative action plans for qualified individuals with disabilities and protected Veterans are available for inspection in the Office of Institutional Equity, Monday through Friday, from 9:00 a.m. to 5:00 p.m., upon request.

As a Florida public university, UCF makes all application materials and selection procedures available to the public upon request. 

The University of Central Florida is proud to be a smoke-free campus and an E-Verify employer.

Associate Director, Compliance and Project Support, Automation Biologics

Location – Visp, Switzerland

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 site in Visp, Switzerland is growing and for our Biologics organization, we are seeking a senior Manager Automation who can manage our Compliance and Project Support team with significant experience in DeltaV and MES and a passion for Biotechnology to join our Lonza talent community. Become part of this exciting opportunity and apply now for the position as senior Manager Automation Ops Readiness.

Key Responsibilities:

• Managing a team of Senior automation experts and specialists with full responsibility for all aspects of human resource management such as development, coaching, hiring, pay decisions and discipline issues;
• Managing a local Center of Excellence for Operations Automation (Delta V, Syncade) of bioprocesses;
• Working with the team in Capital investment projects and strengthening the respective automation teams with expert knowledge on process automation;
• Working with the global Center of Excellence to standardize automation approaches in biopharma manufacturing;
• Providing high-level troubleshooting support with the team;
• Collaborating with the Operations to provide resource plans for automation set-up;
• Driving the ambition level for automation in the design of the facilities by incorporating innovation, operational improvements, and other aspects influencing the manufacturing costs;
• Contributing automation expertise to design development teams;
• Managing the automation teams during the initial engineering phases and providing leadership to cross-functional teams of experts;
• Supporting LONZA culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside specific area of responsibility.

Key requirements:

• Recognized expert in the area of Bioprocess Automation (OT, Delta V, MES Syncade)
• Deep understanding of bioprocesses, GMP and biopharma production
• Strong leadership skills
• Ability to communicate internally and externally at higher levels; strong business understanding, strong team orientation
• Structured and proactive working attitude
• Open-minded for new ideas

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.

#LI-SG

At Niagara, we’re looking for Team Members who want to be part of achieving our mission to provide our customers the highest quality most affordable bottled water.

Consider applying here, if you want to:   

• Work in an entrepreneurial and dynamic environment with a chance to make an impact.   
• Develop lasting relationships with great people.   
• Have the opportunity to build a satisfying career.

We offer competitive compensation and benefits packages for our Team Members.

The Sr. Director of Quality Assurance - Aseptic & Beverage is responsible for overseeing the sanitary process design, commissionings and quality systems of Niagara Aseptic and Beverage bottling facilities.  This position must ensure all products and processes meet the required Food Safety and Product Quality Standards.  This should include but not be limited to our Niagara Sanitation standards and policies for both Aseptic and Beverage bottling locations.

This position will provide quality and food safety oversight for Beverage and Aseptic projects including, but not limited to new beverage technologies, potential cost savings, efficiency improvements, CIP extensions, equipment retrofits, process improvements, new product rollouts, and other miscellaneous projects as dictated by customer needs.  This position is also responsible for providing technical support to other cross functional departments, including scoping of new sales opportunities and ongoing customer discussions.

This position reports to the Vice President of Quality Assurance, Beverage.

Essential Functions

• The Sr. Director of Quality Assurance, Beverage & Aseptic will oversee the development and maintenance of all Niagara Quality Assurance procedures, policies, and standards in use by our Beverage and Aseptic bottling locations and applicable bottled water lines and facilities.  This includes but is not limited to the Sanitation procedures, policies, and standards for both Beverage and Aseptic. 
• Ensure that all Aseptic, Beverage, and Sanitation Quality Assurance standard operating procedures (SOPs), policies, and standards are written with the intent of assuring that all finished products meet and/or exceed the product/packaging standards as set forth by Niagara Bottling, FDA, local state requirements, and ISBT and IBWA (where applicable). 
• Provide technical expertise and collaborate with Engineering and OEMs in designing and validating Aseptic and Beverage bottling systems, including but not limited to kitting, batching, thermal processes, sanitation and bottling.
• Assist Engineering with the development of Aseptic and Beverage equipment and process specifications to satisfy requirements of current and future products.
• Collaborate with vendors, corporate project managers and plant operations to support Aseptic and Beverage equipment installation with the objective to ensure a successful commissioning.
• Oversee the development and implementation of Niagara Aseptic, Beverage, and Sanitation Quality Assurance SOPs, policies, and standards through the necessary plant and corporate personnel within Niagara Bottling. 
• Oversee and ensure bottling facilities meet and are prepared to successfully complete the necessary audits and maintain all documentation required for federal/state regulatory inspections, kosher certificates, SQF certificates, 3rd party customer audits, etc. 
• Interacting with our Corporate Quality Program Manager and Consumer Affairs as needed by collecting and organizing the necessary information and/or corrective actions when customer and/or consumer complaints are received on products/packages.  Communicate these CAPAs to customers as needed.    
• Be the technical point person for Niagara Aseptic, Beverage and Sanitation information and quality related issues. 
• Ensure the necessary Corporate Quality personnel are on site for all new plant, line or process start-ups, commissionings, new beverage formulation and/or reformulations as needed.  This may include but not be limited to Beverage, Sanitation, and Bottled Water treatment processes as applicable.
• Ensure the necessary Corporate Quality personnel are on site when necessary to assist with customer commissionings, visits and/or audits.  Interact with customer’s quality assurance department when technical information is requested. 
• Work with Corporate Supplier Quality to develop/implement the necessary ingredient quality requirements.  Provide the necessary technical oversight and dispositions of expedited ingredient shipments.
• Represent Niagara at association or certification body meetings as needed.  This may include, but not be limited to ISBT, AIB, IBWA, and SQF. 
• Formulate and manage the development and implementation of Aseptic and Beverage group’s goals, objectives, and job designs.
• Travel requirement of 25% to 50% (domestic and international).
• Please note this job description is not designed to contain a comprehensive list of all activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without prior notice.

Qualifications

• Required:
  • 10+ years - Experience in Beverage Quality Assurance
  • 10+ years - Experience with the operation and oversight of Beverage Sanitation processes
  • Experience with GFSI certification standards

*Experience may include a combination of work experience and education

• Preferred:
  • 10+ years  – Experience in Quality Assurance for a beverage (hot-fill, aseptic, or CSD) manufacturer
  • 10+ years – Experience with operation of water purification/treatment processes
  • Experience with ISBT, AIB, IBWA, SQF Food Safety and Quality Certification standards

*Experience may include a combination of work experience and education

Competencies

• Working technical knowledge of Beverage processes, products, and packages including but are not limited to hot fill, cold fill, HTST, CSD, high acid aseptic, and low acid aseptic. 
• Working knowledge and understanding of the CQV (Commissioning, Qualification, Verification) process
• Excellent technical communication skills at all levels. Ability to positively influence, support and lead corporate as well as plant QA Departments and quality teams.
• Implementation and monitoring of all quality standards, procedures and policies such as HACCP, GMPs, SOPs, SPC and Food Safety.
• Ability to present information and respond to questions from groups of VPs, PDs, directors, managers, employees, or customers.
• Participate in proactive team efforts to achieve departmental and company goals.
• Provide leadership and training to others through example and sharing of knowledge.
• Must be able to make independent judgments on issues affecting food safety and quality assurance procedures, forms, policies, and standards.
• Strong organization and planning skills with ability to multi task.
• Must work well under pressure in a very fast paced environment.
• Understand and support the customer’s business: new product and packaging trends, ingredient contributions and packaging trends.
• Microsoft Office, Word, Excel and Outlook

This position embodies the values of Niagara’s LIFE competency model, focusing on the following key drivers of success:

• Lead Like an Owner
  • Manages a safe working environment, accurately documents safety related training, and effectively communicates safety incidents
  • Provides strategic input and oversight to departmental projects
  • Makes data driven decisions and develops sustainable solutions
  • Skilled in reducing costs and managing timelines while prioritizing long run impact over short term wins
  • Makes decisions by putting overall company success first before department/individual success
  • Leads/facilitates discussions to get positive outcomes for the customer
  • Makes strategic decisions which prioritize the needs of the customer over departmental/individual goals
• InnovACT
  • Continuously evaluates existing programs and processes, and develops new initiatives to increase efficiency and reduce waste
  • Creates, monitors, and responds to departmental performance metrics to drive continuous improvement
  • Communicates a clear vision, organizes resources effectively, and adjusts the strategy as needed when managing change
• Find a Way
  • Demonstrates ability to think analytically and synthesize complex information
  • Effectively delegates technical tasks to subordinates
  • Works effectively with departments, vendors, and customers to achieve organizational success
  • Identifies opportunities for collaboration in strategic ways
• Empowered to be Great
  • Makes hiring decisions primarily based on culture fit and attitude, and secondarily based on technical expertise
  • Engages in long term talent planning
  • Provides opportunities for the development of all direct reports
  • Understands, identifies, and addresses conflict within own team and between teams

Education

• Minimum Required: 
  • Bachelor’s Degree in related field or equivalent work experience
• Preferred:
  • Master’ Degree in related field or equivalent work experience

Certification/License:

• Required:    NA
• Preferred:   CPO IBWA, HACCP, PCQI, SQF practitioner

Typical Compensation Range

Benefits

https://careers.niagarawater.com/us/en/benefits

Any employment agency, person or entity that submits a résumé into this career site or to a hiring manager does so with the understanding that the applicant's résumé will become the property of Niagara Bottling, LLC. Niagara Bottling, LLC will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity.

Employment agencies that have fee agreements with Niagara Bottling, LLC and have been engaged on a search shall submit résumé to the designated Niagara Bottling, LLC recruiter or, upon authorization, submit résumé into this career site to be eligible for placement fees.

Sales - Client Relationship Director
Location - London International House (Hybrid)
Salary - Competitive + Commission

Our mission within the Enterprise sales team is to work with our customers to identify areas of growth, areas where we do not currently deliver into and new projects to support customer outcomes.

To achieve this goal, we need to supercharge growth and drive new business opportunities into accounts that sit within the Enterprise world.

Day in Life of a Client Relationship Director
Identify, liaise and influence a range of stakeholders including c-level contacts within customers to maximise high value, long-term sales opportunities and account yield.
Prospect for new revenue streams whilst maintaining and growing existing lines of revenue .
Develop and nurture relationships with senior stakeholders in order to drive new business streams within existing clients.
Effectively direct client scoping meetings with internal and external stakeholders to understand complex customer requirements and create opportunities
Prepare and lead large scale bids, proposals and presentations to meet customer requirements with relevant internal SME's owning the process end to end.
Input, analyse and interpret all relevant sales MI data to prioritise your opportunity pipeline and identify account growth opportunity utilising Microsoft Dynamics

What You'll' Bring
Good communication for internal and external stakeholders up to C suite level
Driven and hungry for the sale
Dynamic and innovative
Willing to challenge the status quo
Demonstrable success in sales


A little about QA:
At QA, our mission is powering people's potential.
We believe the answer to closing the digital skills gap lies with the people organisations already have and the talent we can bring for the future. We're experts in reskilling, upskilling, apprenticeships, and other talent needs for leading enterprises and public sector organisations in the UK and we're proud to work with some of the world's biggest brands including the BBC, AWS, Google, Deloitte, JP Morgan as well as small organisations to give them the competitive edge in the digital world of today. Our bespoke and customisable training methods, learning programmes and talent acquisition solutions cover all digital requirements including emerging and in-demand tech skills to transform the workforce and fuel the success of businesses.

You can find out more about Life at QA here.

Down time
Taking time for ourselves is so important these days which is why we dedicate some of our benefits to support your health & wellbeing. These include: 27 days holiday each year, holiday buying scheme, Medicash plan, Gympass, Cycle to Work scheme, Employee Assistance Programme, and 2 days per year charity leave.
You'll also have the chance to be part of the 110 Club, an amazing incentive-based reward for our Sales Teams, which will see you go on a fantastic all expenses paid VIP weekend abroad! Recent destinations include Las Vegas, Miami, New York.


How we'll help with finance matters
In addition to pension, group income protection and life assurance, QA are offering you an annual pay review, access to our employee discounts benefit hub with hundreds of deals and savings on goods and experiences, season ticket loan, tech scheme and an employee referral scheme.


Personal growth
Learning and opportunity is at the core of what we do - and that applies to you too!
You'll have the unique opportunity to develop your skills on our QA authored courses in the latest tech (you'll get 3 training days/year to do this). You can also delve deep into our world-class digital learning content from Circus Street and Cloud Academy on a variety of tech and business topics. Or perhaps you'd like to enrol on a Degree or Masters programme to enhance your skillset or learn new things.


Our people
We are an equal opportunity employer, focused on promoting a welcoming and inclusive environment. We embrace diversity, welcome applications from all candidates and aim to support the career growth of everyone. This means no matter what your gender, age, ethnicity, beliefs, or sexual preference, or if you are disabled or a carer, we welcome you and the alternative perspectives you bring to our diverse family. We're proud of the progress we've achieved over the last few years to build an inclusive culture and celebrate our diversity - our rankings on The Inclusive Top 50 UK Employers List are a testament to this.


We are proud to be a Disability Confident employer. All applicants with a disability who fulfil the role criteria will be progressed to the next stage of the process. Please let us know what reasonable adjustment, if any, you require.


If this is what you're looking for, here are the next steps:

Hit the apply button and register on our QA website to fill out our quick and easy application form. If you'd like to hear more about the role you can find me on LinkedIn - Giselle Rodrigues or email me: - happy to help!

#LifeatQA #QA #theresnoplacelikeqa #LI-GR1 #LI-hybrid #hiring

Proud member of the Disability Confident employer scheme