Associate Director, Principal Product Quality Lead

Associate Director, Principal Product Quality Lead

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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 is work that transforms the lives of patients, and the careers of those who do it.

You'll get 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.

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 the lifecycle management of a commercial cell therapy product, providing direct technical and quality compliance oversight of the commercial program to ensure regulatory compliance of GMP operations. The PQL will drive alignment across cell therapy programs with appropriate regulatory expectations and global compliance requirements.

They will lead technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage strategies for Quality to meet product goals. The PQL will develop and roll‑out product quality frameworks for end‑to‑end quality management of commercial manufacturing, lifecycle improvements, and control strategies. They are a matrixed leader, planning strategic implementation of commercial requirements while supporting program progress in the evolving cellular therapeutic field.

The PQL works directly with QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences & Technologies, Regulatory Affairs, and other Cell Therapy Development Organizations on issues related to process and manufacturing, control strategy, analytical methods, specifications, reference standards, stability, investigations, change control, product complaints, and regulatory submissions. They have oversight and decision authority over multiple aspects of the program including analytical, process lifecycle changes, regulatory submissions, and health authority communications.

• Provide global product quality oversight and support for external manufacturing/partnerships and internal manufacturing operations, including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences & technology, and regulatory affairs functions.
• Support the overall product quality strategy based on CMC deliverables, technical team objectives, lifecycle improvements, and regulatory commitments.
• Provide technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies to support lifecycle management activities.
• Review clinical and commercial regulatory filings as needed.
• Demonstrate influence through persuasive interactions and garner support for novel solutions.
• Operationalize theoretical concepts into actionable plans and execute them with successful outcomes.
• Chair Analytical Subteam meetings between 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 product 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 regarding the assigned product, owning global changes and…