Bristol Myers Squibb
Associate Director, Principal Product Quality Lead
Bristol Myers Squibb, Seattle, Washington, us, 98127
Associate Director, Principal Product Quality Lead
Join to apply for the
Associate Director, Principal Product Quality Lead
role at
Bristol Myers Squibb
Working with Us Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department, from optimizing a production line to the latest breakthroughs in cell therapy. This work transforms the lives of patients and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Summary Bristol‑Myers Squibb is seeking an Associate Director, Principal Product Quality Leader (PQL) in Global Product Quality to support commercial projects within the Cell Therapy organization. The PQL will oversee lifecycle management of a commercial cell therapy product, providing direct technical and quality compliance oversight (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations. The PQL will drive alignment across cell therapy programs, provide technical expertise and leadership to Product CMC/Quality teams, develop and roll‑out product quality frameworks, and manage the quality strategy for commercial manufacturing, life‑cycle improvements and control strategies.
Key Responsibilities
Provide global product quality oversight and support for external manufacturing/partnerships and internal manufacturing operations, including maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.
Support the overall product quality strategy based on CMC deliverables, technical team objectives, life‑cycle improvements, and regulatory commitments.
Provide technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies for life‑cycle management activities.
Review clinical and commercial regulatory filings as needed.
Influence others through persuasive interactions and garner support for novel solutions where applicable.
Operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
Chair the Analytical Subteam meetings between Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences and Technology, Product Sciences, and Regulatory Affairs.
Coordinate program‑specific presentations to the Product Quality Review Board, Product Specification Committee and other‑quality related cross‑functional teams.
Serve as QA reviewer/approver for analytical and process protocols and reports, stability protocols and reports.
Own product release and stability specifications and strategy.
Provide strategic guidance and facilitate timely implementation of global changes related to the assigned product, owning global changes and documentation management activities as required.
Assist in the continuous improvement and lifecycle management of GMP operations, including guidance for transitioning from clinical to commercial phase.
Serve as quality oversight for product and stability trend investigations.
Qualifications
BS/MS in a relevant science or engineering discipline and 10+ years of experience in quality in a biotech, pharmaceutical or bio‑pharmaceutical organization; 1–3 years of experience in a supportive PQL role preferred.
Expertise in lentiviral vector manufacturing or analytics with validation experience is a plus.
Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle required.
Experience with review of market applications, IND, supplements or similar regulatory documentation required.
Demonstrated technical skill set with analytics and/or process development preferred.
Demonstrated decision‑making and problem‑solving ability required.
Demonstrated quality leadership through partnership in a matrixed organization required.
Background in vaccines, biologics or cell therapy manufacturing required.
Demonstrated ability to work cross‑functionally and to develop and maintain strong business partner relationships.
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and to engage and influence team members in a matrixed environment.
Must effectively operate and deliver in a continuously evolving regulatory and operations landscape.
Compensation Overview Devens, MA – $174,260 – $211,160 Madison, NJ – $162,860 – $197,348 Seattle, WA – $179,140 – $217,073
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities may be available. Final, individual compensation will be decided based on demonstrated experience.
Benefits Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health coverage: medical, pharmacy, dental and vision care.
Well‑being support: programs such as BMS Well‑Being Account, BMS Living Life Better and Employee Assistance Programs (EAP).
Financial well‑being and protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support and survivor support.
Work‑life benefits include
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays—excludes Phoenix, AZ, Puerto Rico or Rayzebio employees).
Phoenix, AZ, Puerto Rico and Rayzebio exempt, non‑exempt, hourly employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
Additional time off for eligible employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement and military needs, and an annual global shutdown between Christmas and New Years Day.
All global employees full and part‑time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible for the global shutdown.
Eligibility disclosure: the summer hours program is for U.S. office‑based employees due to the unique nature of their work. Employees in remote‑by‑design or lab‑based roles may be eligible; contractors, leased workers and other service providers are not eligible.
Uniquely Interesting Work, Life‑changing Careers With a single vision as inspiring as Transforming patients’ lives through science™, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Supporting People With Disabilities BMS 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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Job Details Job Title: Associate Director, Principal Product Quality Lead Requisition: R1597688
Referrals Referrals increase your chances of interviewing at Bristol Myers Squibb by 2x.
#J-18808-Ljbffr
Associate Director, Principal Product Quality Lead
role at
Bristol Myers Squibb
Working with Us Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department, from optimizing a production line to the latest breakthroughs in cell therapy. This work transforms the lives of patients and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Summary Bristol‑Myers Squibb is seeking an Associate Director, Principal Product Quality Leader (PQL) in Global Product Quality to support commercial projects within the Cell Therapy organization. The PQL will oversee lifecycle management of a commercial cell therapy product, providing direct technical and quality compliance oversight (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations. The PQL will drive alignment across cell therapy programs, provide technical expertise and leadership to Product CMC/Quality teams, develop and roll‑out product quality frameworks, and manage the quality strategy for commercial manufacturing, life‑cycle improvements and control strategies.
Key Responsibilities
Provide global product quality oversight and support for external manufacturing/partnerships and internal manufacturing operations, including maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.
Support the overall product quality strategy based on CMC deliverables, technical team objectives, life‑cycle improvements, and regulatory commitments.
Provide technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies for life‑cycle management activities.
Review clinical and commercial regulatory filings as needed.
Influence others through persuasive interactions and garner support for novel solutions where applicable.
Operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
Chair the Analytical Subteam meetings between Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences and Technology, Product Sciences, and Regulatory Affairs.
Coordinate program‑specific presentations to the Product Quality Review Board, Product Specification Committee and other‑quality related cross‑functional teams.
Serve as QA reviewer/approver for analytical and process protocols and reports, stability protocols and reports.
Own product release and stability specifications and strategy.
Provide strategic guidance and facilitate timely implementation of global changes related to the assigned product, owning global changes and documentation management activities as required.
Assist in the continuous improvement and lifecycle management of GMP operations, including guidance for transitioning from clinical to commercial phase.
Serve as quality oversight for product and stability trend investigations.
Qualifications
BS/MS in a relevant science or engineering discipline and 10+ years of experience in quality in a biotech, pharmaceutical or bio‑pharmaceutical organization; 1–3 years of experience in a supportive PQL role preferred.
Expertise in lentiviral vector manufacturing or analytics with validation experience is a plus.
Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle required.
Experience with review of market applications, IND, supplements or similar regulatory documentation required.
Demonstrated technical skill set with analytics and/or process development preferred.
Demonstrated decision‑making and problem‑solving ability required.
Demonstrated quality leadership through partnership in a matrixed organization required.
Background in vaccines, biologics or cell therapy manufacturing required.
Demonstrated ability to work cross‑functionally and to develop and maintain strong business partner relationships.
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and to engage and influence team members in a matrixed environment.
Must effectively operate and deliver in a continuously evolving regulatory and operations landscape.
Compensation Overview Devens, MA – $174,260 – $211,160 Madison, NJ – $162,860 – $197,348 Seattle, WA – $179,140 – $217,073
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities may be available. Final, individual compensation will be decided based on demonstrated experience.
Benefits Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health coverage: medical, pharmacy, dental and vision care.
Well‑being support: programs such as BMS Well‑Being Account, BMS Living Life Better and Employee Assistance Programs (EAP).
Financial well‑being and protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support and survivor support.
Work‑life benefits include
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays—excludes Phoenix, AZ, Puerto Rico or Rayzebio employees).
Phoenix, AZ, Puerto Rico and Rayzebio exempt, non‑exempt, hourly employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
Additional time off for eligible employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement and military needs, and an annual global shutdown between Christmas and New Years Day.
All global employees full and part‑time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible for the global shutdown.
Eligibility disclosure: the summer hours program is for U.S. office‑based employees due to the unique nature of their work. Employees in remote‑by‑design or lab‑based roles may be eligible; contractors, leased workers and other service providers are not eligible.
Uniquely Interesting Work, Life‑changing Careers With a single vision as inspiring as Transforming patients’ lives through science™, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Supporting People With Disabilities BMS 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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Job Details Job Title: Associate Director, Principal Product Quality Lead Requisition: R1597688
Referrals Referrals increase your chances of interviewing at Bristol Myers Squibb by 2x.
#J-18808-Ljbffr