Total 9 Director/C-Level Quality Assurance / Control job vacancies in Anywhere in the U.S. (remote job), United States

• Implements and sustains a comprehensive quality assurance and patient safety programs.
• Leads, develops and manages strategies for measurement aligned with external and internal benchmarks and standards of quality, patient safety, patient experience and risk management.
• Aligns activities, policies, process guidance and analysis (measurement, review, examination) with accreditation standards for quality, patient safety, patient experience, and risk management defined by TJC and AAAHC and industry recognized best practices from reputable sources.
• Develops work plans and performance evaluation criteria; ensures subordinates achieve Agency goals. Provides management direction and leadership under the general direction of the Office Director. Provides leadership, guidance, and direction for the IHS programs supporting and ensuring quality assurance, compliance, patient safety, and risk management. Formulates budget requests and develops related supporting justification narratives to meet program objectives of ensuring consistently high quality in all IHS clinical operations.
• Plans work to be accomplished by subordinates, set and adjust short-term priorities, and prepare schedules for completion of work; Assigns work to subordinates based on priorities, selective consideration of the difficulty and requirements of assignments, and the capabilities of employees; Evaluate work performance of subordinates; Gives advice, counsel, or instruction to employees, and refers group grievances and more serious unresolved complaints to a higher-level supervisor or manager; Interviews candidates for positions in the unit; recommends appointment, promotion, or reassignment; Hears and resolves complaints from employees, refers group grievances and more serious unresolved complaints to a higher-level supervisor or manager; Effects minor disciplinary measure of warnings and reprimands, and recommends other action in more serious cases; Identifies
  developmental and training needs of employees, provides or arranges for needed development and training; Finds ways to improve

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsible for providing leadership, direction, and management of all mechanical & electrical supplier-engagement activities in the HDD Operations

Main Interfaces:

The main customer is Factory and Development Engineering to ensure suppliers are qualified by QSR and capable of supporting HVM production, excursion-free.

Key partners include:

• Global Commodity Management (Direct & Indirect)
• OCCQ – Product Quality, Factory Quality, Customer Quality
• SPMO, Mfg/Product Engineering & Analytical Services
• Dev Engineering including validation team (QA-PMs)

Primary Accountabilities:

1) Lead, manage and develop the SQE team:

• Recruit, train and develop the SQE subject matter expertise
• Review progress, customer feedback and monitor KPIs
• Establish tools/processes/systems for higher productivity
• Regular reviews on career and growth

2) Supplier-Component/Sub-Assembly Level:

• Timely qualification (QMP, AVL approval )to support new product ramp readiness
• Roadmap initiatives (Variability Reduction, FMEA+, ZDM) technology transitions at suppliers for continuous process capability and process robustness improvement
• Deep dive session reviewing supplier improvement & engagement progress, review action plans to meet KPI and stretch targets
• Engage supplier’s executives during Get Well plan

3) WD Cross-Functional Facilitation:

• Design for Manufacturability and ensure specs are complete
• Create Lessons Learned to feedback design rules
• Recommend and influence supplier selection list for new product
• Support alternate source qualification in times of supply chain disruption (due to covid or natural disasters)
• Supplier ratings (QBR) and supplier selection

4) Other Collaboration:

• With Factory team to resolve and prevent component quality excursions
• With Mfg Engineering to resolve not fit-for-use issues
• With Product Engineering on optimization to improve drive yield

Your new company
Hays have been exclusively retained by an extremely well-funded biotech driving breakthrough innovations in the space of gene therapy.They have developed an innovative new technology that allows them to deliver gene therapies in a novel way to patients with rare diseases and are currently going into their initial clinical trial to validate its use. Alongside this they have multiple other programmes approaching the clinic and several more in development, giving them a very strong pipeline.The company prides itself on innovation and collaborative work and has a very experienced senior leadership & technical team coupled with a C-suite with a truly impressive track record.
They are looking to add a Director / Senior Director of Process and Compliance to help them move the company's Clinical Technologies forward and are offering an excellent package plus significant remote working flexibility and the chance to make a real impact.


Your new role
This is a permanent position, working closely with the CEO, VP Biometrics and other senior stakeholders to ensure clinical (and potentially other, earlier discovery) technologies remain compliant with regulatory requirements as well as driving innovation within this space, eg through the adoption of new processes/technologies/software, etc.The company is ideally looking for candidates to spend some time in office, but the exact amount is open for discussion dependent on candidate location and other factors.
Major responsibilities will include a mix of (but aren't limited to):

• Establish the implementation roadmap for all clinical technologies that enable clinical trial management and data collection mechanisms
• Develop, manage and implement processes for clinical technology adoption and management, eg software solutions
• Drive new technology solutions for site visits, clinical monitoring, risk management and provide clinical operations colleagues with innovative ways to make a broader impact on the lives of the patients in our studies
• Oversee / manage projects to integrate and implement new technologies within clinical data capture or similar
• Manage the creation of new - and optimisation of existing - quality management processes
• Liaise with colleagues, eg within IT, Clinical Operations, Biometrics, QA & Regulatory Affairs, to ensure clinical trial activities are properly integrated / aligned to protocols
• Manage, implement, and develop solutions in site start-up, study recruitment/conduct, and data capture processes across multiple clinical technology programmes
• Act as a technical expert and leader within the business
• Drive best practice within the business

What you'll need to succeed
As well as strong communication skills for dealing with collaborators, stakeholders and vendors/CROs, you should have:

• A BSc (or equivalent experience) in a discipline such as computer science, biometrics, statistics, IT, or a life sciences discipline such as chemistry, biochemistry or biology
• Experience of the clinical drug development environment including experience in clinical software development and application deployment is essential, whether from a QA/CSV standpoint, or the data management/clinical operations side
• Deep expertise of regulatory requirements and industry standards relevant to clinical research, ensuring compliance throughout all stages of clinical trials
• Proven ability to design and/or develop technology solutions deployed in clinical trials - such as CTMS or other relevant technologies

Familiarity with navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes

• Well-versed in the utilisation of common tools and technologies within clinical trials, including TMF, CTMS, DCT, and eSource, EDC, etc
• The ability to manage multiple concurrent projects and effectively prioritise between competing requirements

Experience of rare disease / small cohort trials would be an advantage, but is not necessary for this role.


What you'll get in return
You'll get the chance to make a significant impact on the company's clinical development and R&D/discovery projects, taking on project leadership for a number of different aspects, driving the adoption of new protocols and processes to make their operations as innovative and effective as possible whilst maintaining compliance with regulatory standards.The company are very flexible on salary bands and package depending on the skills of the person coming in and you will be a key member of a highly experienced team, with direct access to the C-suite leadership.


What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call me on 0203 465 0057.If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career, especially as there are a number of other bioinformatics, data science and statistics positions available.

Keywords: clinical, data, management, manager, quality, systems, process, compliance, controls, tools, CSV, validation, regulatory, compliance, computer, systems, SDTM, ADAM, CDISC, SAS, Snowflake, QA, audit, 21-CFR Part 11, Director, VP, drug, development, R&D, discovery, IT, pharmaceutical, biotech, operations

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

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:

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!

Position Overview

In this role, you will implement strategies and operational improvements for the Volume businesses of Global License Compliance (GLC). Your responsibilities will include coaching the GLC sales personnel, managing third-party organizations, and ensuring the efficient operation of the North American business.

Reporting to the Senior Director of GLC, AMER, you will also develop business processes and strategies to exceed Autodesk GLC's key objectives for its North American Territory Sales. Working collaboratively with the executive staff and key internal stakeholders, you will drive policies and programs in line with the organization's strategic and operational priorities.

Responsbilities:

• Monitor the policies, practices and processes of GLC North America to determine efficiency and effectiveness. Recommend improvements and develops strategies to achieve and deliver improved results. Implement and follow standards as defined by Corporate and Division senior management; escalate exceptions or questionable practices to direct manager or senior management staff. This may include working with various data support teams, legal, PPL, and Corporate Compliance.
• Regularly interact with executives and/or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization.
• Manage and lead a team of top accomplished License compliance sales professionals to exceed assigned quotas, ensuring team efficiency and revenue goals are met. Responsible for the hiring, team effectiveness, culture, performance management and skill development of this team.
• Deliver timely and accurate forecasting of the business, within 2% variance, and pipeline management.
• Manage and develop resources (including consultants, vendors and remote workers, which may be in different time zones). This includes selection, mentoring/coaching, performance management and assessment, and rewards and recognition within own team.
• Work on complex issues where analysis of situations or data requires an in-depth knowledge of Autodesk, its licensing models, and industry best practices. Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensure budgets and schedules meet corporate and divisional requirements.
• Lead or sponsor cross functional or intra-divisional projects for Global License Compliance North America, especially projects related to streamlining and/or improving processes and systems.
• Lead the way in working collaboratively with Territory sales teams on account planning activities to ensure the best customer experiences.
• Manage sales KPIs, pipeline and activity metrics (all leading indicators) of team to ensure these are tracking towards achievement of revenue goals, while ensuring that a balance of sales and enforcement activity is maintained.
• Strategically monitor and review long term goals of the program and ensure campaigns are executed within budget and that License Compliance revenue targets are met.
• May make presentations to existing and prospective customers about the benefits of Autodesk software and engage in final stage negotiation with C level customers and be a point of escalation.
• Manage both Direct and Indirect sales motions.
• Manage a complex volume business that may include highly technical lead sources; responsible for prioritizing various lead programs for the team to maximize effectiveness of the business.
• Collaborates on best practices and drives License Compliance strategies with other geographies and functional groups.

Minimum Qualifications

• 10+ years of relevant experience in technical software or SAAS/PAAS sales; 5+ sales leadership experience with track record of creating high-performing teams.
• Sales experience includes track record of success in difficult negotiations with C-level, handling accounts in the enterprise segment, and conflict resolution.
• Experience in effectively managing a complex, volume-based and digital business and comfortable interfacing with stakeholders at all seniority levels.
• Familiarity with technology, licensing models, and business trends in Autodesk target industries.

Preferred Qualifications:

• Experience or knowledge in Cyber security practices or License Compliance industry
• Experience selling in value-based models
• Ability to build relationships at multiple levels
• Self-motivated with the ability to adapt to changing priorities and business initiative

About Autodesk

Welcome to Autodesk! Amazing things are created every day with our software – from the greenest buildings and cleanest cars to the smartest factories and biggest hit movies. We help innovators turn their ideas into reality, transforming not only how things are made, but what can be made.

We take great pride in our culture here at Autodesk – our Culture Code is at the core of everything we do. Our values and ways of working help our people thrive and realize their potential, which leads to even better outcomes for our customers.

When you’re an Autodesker, you can be your whole, authentic self and do meaningful work that helps build a better future for all. Ready to shape the world and your future? Join us!

Benefits

From health and financial benefits to time away and everyday wellness, we give Autodeskers the best, so they can do their best work. Learn more about our benefits in the U.S. by visiting https://benefits.autodesk.com/

Sales Careers

Working in sales at Autodesk allows you to build meaningful relationships with customers while growing your career. Join us and help make a better, more sustainable world. Learn more here: https://www.autodesk.com/careers/sales

Equal Employment Opportunity

At Autodesk, we're building a diverse workplace and an inclusive culture to give more people the chance to imagine, design, and make a better world. Autodesk is proud to be an equal opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, age, sex, sexual orientation, gender, gender identity, national origin, disability, veteran status or any other legally protected characteristic. We also consider for employment all qualified applicants regardless of criminal histories, consistent with applicable law.

Diversity & Belonging

We take pride in cultivating a culture of belonging and an equitable workplace where everyone can thrive. Learn more here: https://www.autodesk.com/company/diversity-and-belonging

Are you an existing contractor or consultant with Autodesk?

Please search for open jobs and apply internally (not on this external site).

Your opportunity

IQVIA, a leading Human Data Science company, is seeking a dynamic and experienced Senior Director of Compliance to join our Ethics and Compliance Office (ECO). In this critical leadership role, you will shape and maintain an effective healthcare compliance program on a global scale. Your responsibilities will span a wide range of duties, ensuring adherence to ethical standards and regulatory requirements.

You will interact regularly with various internal stakeholders, including Legal, Finance, Human Resources, Internal Audit, Global Quality Assurance, Chief Information Office, and all global and regional business units, as well as with external parties such as auditors, law firms, and regulators. 

As a leader, you will be a trusted member of the ECO Leadership Team, managing at least one employee and reporting to the Chief Compliance Officer, and driving a culture of ethics and integrity in all we do.

Your key responsibilities will include:

Strategic Leadership:

• Oversee IQVIA’s Code of Conduct and ethics and compliance policies.

• Manage the Ethics Line, including the Ethics Line mailbox, in accordance with applicable laws and best practices.

• Prepare materials for presentations to IQVIA’s senior leadership, Audit Committee, and external auditors.

• Provide expert guidance to internal stakeholders across Legal, Finance, Human Resources, and other departments.

• Conduct sensitive investigations as needed.

Collaboration and Stakeholder Management:

• Interact regularly with internal teams, including Legal, Finance, Internal Audit, and Global Quality Assurance.

• Build collaborative relationships with external parties such as auditors, law firms, and regulators.

People Leadership:

• Manage at least one employee.

• Report directly to the Chief Compliance Officer.

• Drive a culture of ethics and integrity throughout the organization.

To be successful on this role, you will have qualifications such as:

• Subject Matter Expertise:

  • Stay informed about global laws, regulations, and codes of ethics.

  • Provide guidance to leadership, management, and employees.

  • JD preferred, or Masters’ degree in legal relevant area, and at least 10 years of relevant experience.

  • Sound knowledge and understanding of the legal and regulatory environment in which the company operates; life sciences or healthcare compliance expertise.

• Ethics Line Management:

  • Experience managing an ethics reporting line, maintaining data and analytics, and preparing accurate, compelling presentations for a wide range of audiences including executive leadership, Audit Committee of Board of Directors, external auditors, and regulators in different regions and countries.

  • Ensure compliance with EU whistleblower laws and other relevant regulations.

• Risk Assessment:

  • Utilize deep subject matter knowledge to assess risks across various areas.

  • Experience managing Codes of Conduct and corporate policies.

  • Experienced investigator; able to guide investigations and enhance capabilities for various resources who do not regularly conduct investigations.

  • Excellent analytical and problem-solving skills; ability to synthesize and summarize complex issues.

  • Excellent judgment and discretion, including the ability to handle sensitive and/or confidential information.

You will differentiate yourself if you have:

• Relevant compliance or professional certification: Certified Compliance and Ethics Professional (CCEP), Certified Fraud Examiner (CFE).

• Life sciences outsourcing experience (e.g., CRO).

Location

• IQVIA currently offers remote work arrangements.

• The incumbent must be based anywhere on the East Coast of the United States.

How to Apply

If you are a seasoned compliance professional with a passion for ethics and integrity, we invite you to be part of our mission to advance healthcare through data science. Apply now by visiting our careers page and searching for Job ID R1393190.

We look forward to welcoming a dedicated leader to our team! 🌟

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

DIRECTOR, CLINICAL QUALITY THERAPEUTIC AREA LEAD

Live

What you will do

Job Description

Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ) and be responsible for a team of 5-10 colleagues. The Director, Clinical Quality Therapeutic Area Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program.

Director, Clinical Quality Therapeutic Area Lead will manage end to end Quality Oversight within one of three Therapeutic Areas (TAs): Oncology/Biosimilars, Immunology & Rare Diseases, and General Medicine. The TA Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will be a vital role who develops deep knowledge of the TA’s clinical trials and provides oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Provide oversight for the development and implementation of Quality Plans
• Establish Regional expertise to ensure quality and compliance to local regulations
• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits)
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience

Or

Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience

Or

Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 5 years of managerial experience directly leading people in a multi-tiered organization and an ability to build a high performing team.
• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. (including oversight of CAPAs, deviations, etc.)
• Thorough understanding and deep knowledge of Clinical Development activities / Clinical Trials and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

JOB DESCRIPTION:

WORKING AT ABBOTT:

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

THE OPPORTUNITY:

The Director of Technical Quality Support is responsible for directing a team of quality engineers focused on validation and design control of products and processes, including software and technical quality assurance personnel. Products include PC application software, mobile applications, embedded firmware and hardware products for medical monitoring systems, all digital and cloud products across Abbott’s portfolio. This role leads and directs activities associated with quality, regulatory, and compliance areas of Abbott. Responsible for developing a standard interpretation of regulations for Abbott, facilitating policy development and deployment to the divisions. Actively influence regulations through industry groups and other channels. Provide oversight for FDA communications regarding compliance issues. Provide strategic consulting for the division by interfacing directly with the divisions on policy development and deployment. Develop and assess key metrics. Provide senior management with impact of regulatory changes.

This role will provide oversight and management for the software (digital and embedded) and technical quality organization, ensuring that the quality system requirements for design, validation and qualification for product development and production are effectively established and maintained to meet regulatory requirements.

Work effectively with multiple different divisions and medical device technologies.

Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected.

Responsible for:

Quality assurance activities for software and firmware development for health care products, including both medical and non-medical applications

Quality assurance activities for hardware development for health care products.

Creating and maintaining an efficient, highly motivated, quality engineering organization.

WHAT YOU’LL WORK ON:

• Provide overall direction and leadership for validation, design and qualification to assure product quality for application software, embedded firmware and hardware products for medical monitoring systems.
• Develop, implement and improve quality policies, processes and procedures, automated systems and reporting systems.
• Supports continuous product and process improvement through identifying major site quality risks and product quality metrics; leverages metrics to assist in shaping the strategy of the quality engineering department.
• The incumbent must understand the details of the areas involved. Possess strong leadership skills, an overall knowledge of healthcare industry regulations, ability to effectively negotiate and strong communication skills.
• Provide strategic consulting for programs being developed or implemented.
• Facilitate policy development and deployment throughout the corporation.
• Work to achieve program standardization between businesses.
• Develop and assess metrics for each center.
• Lead and facilitate implementation of new regulations.
• Train our various businesses on new requirements for compliance.
• Standardize approach to implementation of new regulations.
• Provide oversight of quality and compliance goals.
• Interface directly with the divisions on policy development and deployment
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
• Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process, including on-market risk evaluation and assessments. Making decisions on whether or not to take action on market to remedy non-conforming product on-market.
• Utilizes practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC) experience with Agile/Lean software development lifecycle process
• Complies with worldwide regulations, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Assure line of communication with DVP QA and Senior Leaders on critical quality issues that may result in potential business interruption.
• Assure business continuity in leadership positions and critical roles through talent management planning and development.

QUALIFICATIONS:

• Bachelor's Degree in Engineering, Computer Science or technical discipline or equivalent experience in software field.
• Master’s degree in a technical discipline ideal.
• Minimum 10 years in Progressive work experience in software related medical device or high technology industries. Minimum 10 years prior management experience.
• Requires technical background and direct experience of product development activities for software and/or hardware for leading edge medical devices.
• Demonstrated experience in working effectively to ensure quality and compliance requirements are designed/built into the products.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to travel, including internationally >50% of time.

APPLY NOW:

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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