Sr. Director, External Manufacturing 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.

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Position Summary

To define and shape the Quality strategy for global Contract Manufacturing Organizations (CMO) and associated Contract Test Labs (CTLs) management for the Cell Therapy External Manufacturing (ExM) network and to ensure a high level of cGMP compliance and the safety, efficacy, and quality of externally manufactured commercial products. This includes but is not limited to the following areas:

1) CAR T (Cell Banks, Plasmids, Vector, and Drug Product) manufacturing/ testing and evolving Gene Editing technologies for both clinical and commercial products.

2) Areas managed by BMS companies, e.g., 2Seventy Bio (testing) and Orbital Therapeutics (in vivo).

3) Patient Operations as it relates to global Apheresis Centers.

To lead a team of Quality Senior Directors or others in the oversight of the External Manufacturing Network. To build relationships with senior leadership in the CMO and CTL network to support the Virtual Plant Teams (VPTs) and Virtual Analytical Teams (VATs) and to proactively manage and improve CMO Quality performance through risk-based oversight and periodic reviews.

To drive significant impact on current and future business performance through building a functionally excellent infrastructure (knowledge, processes, and systems) to handle moderately complex quality and compliance responsibilities. 

• Support Development of the Quality Strategy and the Quality Planning for the Cell Therapy External Manufacturing Organization and the Quality Global Business unit.

• Owns the strategy of the Cell Therapy External Manufacturing Quality team.

• Ensures all aspects of Quality Management of External Supplier/CMO is carried out according to the standards defined and is regularly reported and assessed for adequacy of performance.

• Develop a high-performance quality culture with the Cell Therapy Vector and External Manufacturing Operations (VExMQ) organization

• Builds strong organizational capability for current and future needs. Recruit and develop global talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.

• Support deployment of operational excellence strategies within VExMQ

• Prepare and manage VExMQ organizational budget 

• Ensures the Quality Assurance Agreements for Suppliers/CMOs are created and maintained according to GMP and requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product.

• Manage/support the resolution of quality and technical problems in alignment with global standards

• Deploys Quality Risk Management Techniques for quality oversight and problem resolution for CMOs to mitigate unacceptable risk in conjunction with BMS Manufacturing/Supply management and Quality.

• Support audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs.  Ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product, or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines.

• Assure appropriate quality governance through performance of management reviews of quality KPIs, metrics, process performance indicators, and quality system signals and ExM CMO supply risks. Initiate corrective actions when necessary and perform fo