Associate Director, Principal Product Quality Lead

Associate Director, Principal Product Quality Lead

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 the lifecycle management of a commercial cell therapy product, providing direct technical and quality compliance oversight for vector, gene editing, and cell therapy projects to ensure regulatory compliance of GMP operations. The role drives alignment across cell therapy programs, develops and rolls out product quality frameworks, and leads cross‑functional teams (QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences, Technology, and Regulatory Affairs) to resolve manufacturing, control strategy, and regulatory issues.

• Provide global product quality oversight for external manufacturing/partnerships and internal operations, maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences, technology, and regulatory affairs.
• Support the overall product quality strategy based on CMC deliverables, technical team objectives, life‑cycle improvements, and regulatory commitments.
• Deliver 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 support novel solutions.
• Apply theoretical concepts to actionable plans and execute them with successful outcomes.
• Chair Analytical Subteam meetings among Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences & Technology, Product Sciences, and Regulatory Affairs.
• Coordinate program‑specific presentations to the Product Quality Review Board, Product Specification Committee, and other cross‑functional teams.
• Act as QA reviewer/approver for analytical and process protocols, stability protocols, and reports.
• Own product release and stability specifications and strategy.
• Provide strategic guidance for timely implementation of global changes and manage global change documentation.
• Assist in continuous improvement and lifecycle management of GMP operations, including transition from clinical to commercial phase.
• Serve as quality oversight for product and stability trend investigations.

• BS/MS in a relevant Science or Engineering discipline with 10+ years of experience in quality within biotech/pharmaceutical settings; 1‑3 years in a supportive PQL role preferred.
• Expertise in lentiviral vector manufacturing or analytics with validation experience is a plus.
• Strong GMP compliance, global regulations, and product development lifecycle knowledge.
• Experience reviewing market applications, INDs, or similar regulatory documentation.
• Demonstrated technical skillset with analytics and/or process development.
• Strong decision‑making and problem‑solving abilities.
• Quality leadership in a matrixed organization.
• Background in vaccines, biologics, or cell therapy manufacturing.
• Ability to work cross‑functionally and maintain strong business partner relationships.
• Proven leadership ability to make difficult decisions logically and influence team members in a matrixed environment.
• Effectively operate and deliver in a continuously evolving regulatory and operations landscape.

Devens, MA: $174,260 – $211,160
Madison, NJ: $162,860 – $197,348
Seattle, WA: $179,140 – $217,073
The starting compensation range for this role is listed above for a full‑time employee. Additional incentive cash and stock opportunities may be available. Salary decisions are based on demonstrated experience.

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, 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,…