Associate Director, Principal Product Quality Lead

Associate Director, Principal Product Quality Lead

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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.

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.

• 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.

• 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…