Current jobs related to Executive Director, Clinical Quality Assurance, R&D Quality - New Brunswick, New Jersey - Bristol Myers Squibb

  • Senior Quality Executive for R&D

    4 weeks ago

    New Brunswick, New Jersey, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Senior Quality Executive for R&D to join our team.Key ResponsibilitiesProvide leadership and expertise on the strategy, activities, and actions...

  • Quality Assurance Coordinator

    4 weeks ago

    New Brunswick, New Jersey, United States New Brunswick Counseling Center Full time

    Job DescriptionThe New Brunswick Counseling Center is seeking a Quality Assurance Coordinator to perform quality assurance functions under the direction of the Director and in accordance with CARF and agency administration.Key Responsibilities:Disseminate information to staff to ensure reinforcement of current policies and procedures.Develop and implement...

  • Quality Assurance Manager

    4 weeks ago

    New Brunswick, New Jersey, United States Omni Inclusive Full time

    Quality Assurance ManagerOmni Inclusive is seeking a Quality Assurance Manager to provide quality support to External Manufacturing Operations (EXM) within a cross-functional team and Product Disposition reviews for drug products manufactured/packaged by Contract Manufacturing Organizations (CMOs).Responsibilities:Support Senior Manager or Director Quality...

  • Senior Quality Assurance Engineer

    4 weeks ago

    New York, New York, United States CapB InfoteK Full time

    Job Opportunity: CapB InfoteK is seeking a skilled Senior Quality Assurance Engineer to join our team. As a key member of our R&D department, you will be responsible for ensuring the highest quality of our products and solutions.Key Responsibilities:* Collaborate with cross-functional teams to design and implement testing strategies* Develop and execute...

  • Clinical Quality Assurance Specialist

    4 weeks ago

    New York, New York, United States Axelon Full time

    Job Summary: Axelon is seeking a highly skilled Clinical Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality and patient safety, with a minimum of 2 years of experience in a clinical setting.Key Responsibilities:Review and interpret clinical cases to ensure efficiency of careCollaborate with healthcare...

  • Quality Assurance Manager

    4 weeks ago

    New Brunswick, New Jersey, United States Prostaff Solutions LLC Full time

    Quality Assurance ManagerProstaff Workforce Solutions is seeking a highly motivated and experienced Quality Assurance Manager to join our client's team in the nutraceutical industry. The ideal candidate will have a strong background in quality assurance and regulatory compliance, with a proven track record of implementing and maintaining quality programs,...

  • Director of Training and Quality Assurance

    4 weeks ago

    New York, New York, United States Waldorf Astoria Hotels & Resorts Full time

    Director of Training and Quality AssuranceWaldorf Astoria Hotels & Resorts is seeking a highly skilled Director of Training and Quality Assurance to join our team. As a key member of our leadership team, you will be responsible for directing and administering the training and professional development function of our hotel.Key Responsibilities:Oversee and...

  • Quality Assurance Manager

    4 weeks ago

    New Brunswick, New Jersey, United States SOMFY Group Full time

    Quality Assurance RoleIn this challenging position, you will be responsible for ensuring the highest quality standards in our products and services. As a key member of our team, you will work closely with cross-functional departments to identify and implement quality improvements.Key ResponsibilitiesCollect and analyze quality data to identify trends and...

  • Director of Quality Assurance

    4 weeks ago

    New York, New York, United States Sterling Life Sciences Full time

    Director of Quality AssuranceSterling Life Sciences is seeking a highly skilled Director of Quality Assurance to lead their quality management team. The ideal candidate will have a strong background in quality management and a proven track record of ensuring process reliability and compliance with regulatory requirements.Key Responsibilities:Provide...

  • Quality Assurance Inspector

    1 month ago

    New Brunswick, New Jersey, United States Paragon Staffing, LLC Full time

    Job OverviewParagon Staffing, LLC is a leading staffing agency that connects job seekers with top employers. We are currently seeking a Quality Assurance Auditor to join our team.Job ResponsibilitiesThe Quality Assurance Auditor will be responsible for ensuring that products meet established standards of appearance or performance. This will involve...

  • Quality Assurance Specialist, IPQA

    4 weeks ago

    New Brunswick, New Jersey, United States ProStaff Solutions Inc Full time

    Job OverviewWe are seeking a highly skilled Quality Assurance Specialist, IPQA to join our team at ProStaff Solutions Inc. This individual will be responsible for ensuring the quality of our pharmaceutical products by identifying and addressing deviations in the manufacturing process.Key ResponsibilitiesInvestigate and resolve manufacturing process...

  • Quality Assurance Specialist

    4 weeks ago

    New Brunswick, New Jersey, United States Wallenius Wilhelmsen Full time

    Job Summary:As a Quality Assurance Specialist at Wallenius Wilhelmsen, you will be responsible for ensuring the quality of heavy equipment stored at our facility. This includes completing pre-delivery inspections, performing shipping and receiving functions, and maintaining regular communication with internal and external customers.Key Responsibilities:...

  • Quality Assurance Manager

    4 weeks ago

    New Brunswick, New Jersey, United States Seventh Dimension LLC Full time

    Job Summary:Seventh Dimension LLC is seeking a Quality Assurance Manager to oversee requirements and operations onsite for student training mission support of the Drivers Training Support Services (DTSS) at the FLETC. The ideal candidate will have a minimum of three (3) years of consecutive employment in a position with comparable responsibilities in quality...

  • Director of Quality Assurance

    4 weeks ago

    New York, New York, United States Authentic Brands Group Full time

    About the RoleWe are seeking a highly skilled Director of Quality Assurance to join our team at Authentic Brands Group. As a key member of our e-commerce team, you will be responsible for ensuring the quality and reliability of our Shopify-based e-commerce websites.Key ResponsibilitiesDevelop and implement comprehensive QA processes, frameworks, and best...

  • Director of Quality and Outcomes in Cardiology

    4 weeks ago

    New Brunswick, New Jersey, United States Rutgers University Full time

    Job SummaryThe Department of Medicine at Rutgers Robert Wood Johnson Medical School is seeking a highly skilled Director of Quality and Outcomes in Cardiology to lead and oversee the Section. This position offers the opportunity to engage in research and join a team of cardiologists providing clinical cardiology services at Robert Wood Johnson University...

  • Director of Quality and Compliance

    1 month ago

    New Brunswick, New Jersey, United States RWJ New Brunswick Full time

    Job Overview:The Director of Quality and Compliance is responsible for planning, directing, and implementing all aspects of the Regulatory compliance programs and assisting with the planning, directing, and implementing of the Quality program at RWJBarnabas Health.Key Responsibilities:• Develop and implement comprehensive Regulatory compliance programs to...

  • Clinical Development Director

    4 weeks ago

    New York, New York, United States ROIVANT SCIENCES LTD Full time

    Roivant Sciences MissionRoivant Sciences is committed to accelerating the development of promising drug candidates to improve the lives of patients and their families. Our mission is to systematically reduce the time, cost, and risk of delivering new medicines to market.Critical MilestonesSince its inception in 2014, Roivant has achieved several critical...

  • Quality Assurance Specialist for Pharmaceutical Manufacturing

    5 days ago

    New Brunswick, New Jersey, United States ProStaff Solutions Inc Full time

    At ProStaff Solutions Inc, we are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As an IPQA Associate, you will play a critical role in ensuring the quality of our pharmaceutical products and maintaining compliance with cGMP regulations.The ideal candidate will have a strong background in quality assurance and a...

  • Quality Assurance Specialist

    4 weeks ago

    New Providence, New Jersey, United States Globus Medical Full time

    At Globus Medical, we strive to deliver innovative solutions that improve the quality of life for patients with musculoskeletal disorders.Our team is driven by a passion for excellence and a commitment to transforming clinical insights into tangible solutions.We are seeking a Quality Assurance Specialist to join our team and contribute to our mission of...

  • Quality Assurance Specialist

    4 weeks ago

    New York, New York, United States Equus Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Equus Workforce Solutions. In this role, you will be responsible for ensuring that our programs and services are implemented at the highest standards and that our clients receive the highest level of care.Key Responsibilities:Conduct comprehensive audits to ensure...

Executive Director, Clinical Quality Assurance, R&D Quality

4 weeks ago

New Brunswick, New Jersey, United States Bristol Myers Squibb Full time
Transforming Patients' Lives through Science

Bristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Executive Director, Clinical Quality Assurance, R&D Quality to join our team.

This role is a key leader on the R&D Quality Leadership Team responsible for leading the Clinical Quality Assurance function and ensuring the highest standards of quality and compliance in clinical research and related activities.

The Executive Director will work closely with cross-functional teams to support clinical development and ensure the integrity and quality of clinical data and clinical trial subject safety. This leader will sit on key functional area leadership team(s) and also chair key clinical quality councils.

The ideal candidate will have a minimum of 20 years of quality experience or relevant BioPharma experience, with demonstrated experience in R&D and R&D Quality roles. They will have extensive knowledge of GCP, ICH guidelines, and global regulatory requirements for appropriate strategy setting, decision making, and quality oversight to ensure BMS complies with regulatory requirements.

The Executive Director will be responsible for developing and implementing quality assurance strategies, including therapeutic area, process, and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards.

They will also oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and processes/systems, including for-cause and directed activities.

The Executive Director will ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners, and senior management.

They will also lead vendor quality oversight activities and manage external quality (e.g., quality agreements with CROs, set vendor quality councils, etc.).

The Executive Director will develop quality strategies for new clinical trial technology and approaches (e.g., decentralized trials, real-world evidence, digital health, etc.).

They will oversee the development and maintenance of an effective inspection management framework supporting clinical trials.

The Executive Director will provide leadership and oversight for GCP Inspections ensuring effective readiness, preparation, management, and response development and action closure.

They will ensure timely identification, investigation, and resolution of quality issues and non-compliances.

The Executive Director will partner with RBQM in the development of the Quality Narrative, specifically developing and contributing the audit/inspection portion.

They will collaborate with Drug Development and other departments to support clinical programs and ensure quality and compliance.

The Executive Director will engage with executive management and cross-functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, drive issue resolution.

They will provide leadership, guidance, development, and coaching to the CQA team, fostering a culture of quality and continuous improvement.

The Executive Director will ensure CQA team are trained and qualified to perform audit and inspection-related activities.

They will attract, develop, and retain high-quality talent within the organization.

The Executive Director will monitor and interpret regulatory trends and changes, and ensure the company's clinical quality systems are updated accordingly.

They will represent the company in interactions with regulatory agencies.

The Executive Director will develop and deliver training programs to enhance quality awareness and compliance across the organization.

They will prepare and present quality metrics and reports to senior management and other stakeholders.

The Executive Director will lead and chair clinical quality council, partnering with RBQM to ensure relevant clinical trial risks are effectively managed and overseen.

They will manage a fiscally responsible department budget, including operating expenses, staffing level, and outside collaborations.

The Executive Director will engage and influence in external industry consortiums and benchmark opportunities.

Key Responsibilities:

  • Lead the Clinical Quality Assurance function, providing strategic direction and oversight.
  • Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure compliance with GCP, ICH guidelines, and regulatory requirements.
  • Translate risk factors into clinical quality assurance oversight plans, including internal and external audit strategies and inspection readiness/management strategies.
  • Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and processes/systems, including for-cause and directed activities.
  • Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners, and senior management.
  • Lead vendor quality oversight activities and manage external quality (e.g., quality agreements with CROs, set vendor quality councils, etc.).
  • Develop quality strategies for new clinical trial technology and approaches (e.g., decentralized trials, real-world evidence, digital health, etc.).
  • Oversee the development and maintenance of an effective inspection management framework supporting clinical trials.
  • Provide leadership and oversight for GCP Inspections ensuring effective readiness, preparation, management, and response development and action closure.
  • Ensure timely identification, investigation, and resolution of quality issues and non-compliances.
  • Partner with RBQM in the development of the Quality Narrative, specifically developing and contributing the audit/inspection portion.
  • Collaborate with Drug Development and other departments to support clinical programs and ensure quality and compliance.
  • Engage with executive management and cross-functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, drive issue resolution.
  • Provide leadership, guidance, development, and coaching to the CQA team, fostering a culture of quality and continuous improvement.
  • Ensure CQA team are trained and qualified to perform audit and inspection-related activities.
  • Attract, develop, and retain high-quality talent within the organization.
  • Monitor and interpret regulatory trends and changes, and ensure the company's clinical quality systems are updated accordingly.
  • Represent the company in interactions with regulatory agencies.
  • Develop and deliver training programs to enhance quality awareness and compliance across the organization.
  • Prepare and present quality metrics and reports to senior management and other stakeholders.
  • Lead and chair clinical quality council, partnering with RBQM to ensure relevant clinical trial risks are effectively managed and overseen.
  • Manage a fiscally responsible department budget, including operating expenses, staffing level, and outside collaborations.
  • Engage and influence in external industry consortiums and benchmark opportunities.

Qualifications & Experience:

  • Minimum of BA/BS degree or in a life science discipline; advanced education preferred.
  • Minimum 20 years Quality experience or relevant BioPharma experience, with demonstrated experience in R&D and R&D Quality roles.
  • Extensive knowledge of GCP, ICH guidelines, and global regulatory requirements for appropriate strategy setting, decision making, and quality oversight to ensure BMS complies with regulatory requirements.
  • Proven experience in leading and managing quality assurance teams.
  • Strong analytical, problem-solving, and decision-making skills.
  • Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
  • Experience with regulatory inspections and interactions with regulatory agencies.
  • Strong leadership and organizational skills, with a commitment to fostering a culture of quality and compliance.
  • Previous experience dealing with regulatory agencies in policy development, inspections, investigations, and audits.
  • Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
  • Ability to develop/translate long-range strategic plans into short-range operational processes/systems/goals and ability to make sound decisions/recommendations with global perspective.
  • Experience in managing teams, providing coaching, development, and mentoring to employees.
  • Understands the big picture, beyond their own functional area. Enterprise thinker.
  • Broad understanding of digital and data, including AI, automation, advanced analytics, etc.
  • Proven problem-solving skills to prevent and overcome complex process and quality-related issues.
  • Embraces complexity but strives for simplicity. Keen focus on phase-appropriate and risk-based scientific decision making.
  • Creates a vision for the future by spotting strategic opportunities for breakthrough performance. Translates the case for change into actionable plans for the organization.
  • Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.

Why Join Us?

Bristol Myers Squibb is a company that is dedicated to transforming patients' lives through science. We are a leading pharmaceutical company that is committed to innovation, quality, and compliance. Our team is passionate about making a difference in the lives of patients, and we are seeking an experienced Executive Director, Clinical Quality Assurance, R&D Quality to join our team.

As a member of our team, you will have the opportunity to work on challenging projects, develop your skills and expertise, and make a meaningful contribution to the company's success. You will also have access to a comprehensive benefits package, including health insurance, retirement savings, and paid time off.

At Bristol Myers Squibb, we are committed to diversity, equity, and inclusion. We believe that a diverse and inclusive workplace is essential to our success, and we are dedicated to creating an environment that is welcoming and inclusive for all employees.

We are an equal opportunity employer and welcome applications from qualified candidates of all backgrounds. If you are passionate about making a difference in the lives of patients and are looking for a challenging and rewarding career opportunity, we encourage you to apply for this role.

On-site Protocol:

Bristol Myers Squibb has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

  • Site-essential roles require 100% of shifts onsite at your assigned facility.
  • Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
  • Field-based and remote-by-design roles require the ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed.

Bristol Myers Squibb is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit (eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1585267

Updated: :56:24.732 UTC

Location: Summit West-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.