Associate Director, Principal Product Quality Lead, Cell Therapy

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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 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 rich in diversity. Take your career farther than you thought possible.

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Bristol-Myers Squibb is seeking a Product Quality Leader (PQL), Associate Director of Global Product Quality to support early development projects within the Cell Therapy Development Organization.  The PQL will be responsible to oversee programs through clinical implementation through pivotal.  The PQL will provide direct technical and quality compliance oversight of early stage development programs (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.

The PQL must drive alignment across cell therapy programs that are appropriate to the clinical phase, regulatory expectation and global compliance requirements.  The individual will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet product goals. The PQL will develop and roll-out product quality frameworks relating to end-to-end Quality management of clinical manufacturing, life-cycle improvements and control strategies to progress programs to commercial readiness. 

The PQL is a matrixed leader able to plan for strategic implementation of late stage clinical requirements while supporting the progress of the program in the rapidly evolving cellular therapeutic field.  The Product Quality Leader has responsibility for working directly with QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development Organizations on the resolution of issues associated with process/manufacturing, control strategy, analytical methods, specifications, reference standards, stability, investigations, change control, product complaints and regulatory submissions. 

The PQL has oversight and decision authority over multiple aspects of the cell therapy program as it moves through clinical development, including regulatory filings and supporting development reports.

Job Responsibilities

• 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 and technology, and regulatory affairs functions.
• Supports the overall product quality strategy based on CMC deliverables, PD team objectives, life-cycle improvements, and regulatory commitments.
• Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of clinical development efforts and life-cycle management activities.
• Review clinical and commercial regulatory filings as needed.
• Develop and refine the Guidances for product quality requirements along the development continuum 
• Demonstrate the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
• Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
• Coordinates Product Quality Team meetings between Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences and Technology, Product Sciences, and Regulatory Affairs.
• Coordinates program specific presentations to the Product Quality Review Board / Product Specification Committee and other product quality related cross-functional teams
• Serves as QA reviewer / approver for development reports, stability reports, and product specifications  
• Supports Quality oversight and pivotal readiness for early stage programs, providing strategic guidance and facilitation of changes pertinent for pivotal and eventually commercial success
• Provide strategic gui