Senior Director, Global Product Quality, Cell Therapy

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.

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. Read more: careers.bms.com/working-with-us.

Position Summary

The Senior Director, Cell Therapy Global Product Quality Lead (Sr. Dir. CT-GPQL) is accountable for delivering commercially robust and globally compliant quality strategies and outcomes that sustain the product supply chain throughout the product lifecycle. He/She manages product quality risk throughout the product lifecycle, including oversight of process and analytical lifecycle, control strategies, comparability, specifications, and stability. The Sr. Director monitors commercial operations through periodic reviews of process and method performance, including Annual Product Quality Reviews as well as provides general support and leadership within the Global Product Quality organization. The Sr. Director authors designated sections of regulatory filings, reviews all sections for clarity, technical persuasiveness, consistency and completeness, and serves as a subject matter expert and strategist during health authority inspections.

The scope of the role may include one or more cell therapy programs (clinical/commercial), encompassing the internal and external manufacturing and testing of cell banks, gene delivery materials, drug product intermediates, drug product, and finished labeled drug product. This role will partner with Analytical Sciences and Technology, Process and Analytical Development, Manufacturing Sciences and Technologies, Stability, Quality Assurance, Quality Control, GRS CMC to develop and execute product quality strategies. 

Key responsibilities: 

The Senior Director, Cell Therapy Global Product Quality Lead will lead a matrixed team of Product Quality Leaders to: 

• Partner across Global Product Quality, Analytical Sciences and Technology, CT Development and Operations, and CT Regulatory CMC to define and deliver product quality strategies that comply with internal and external quality standards and regulatory requirements. 

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