Sr. Director, External Manufacturing Quality, Cell Therapy

About the role

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.

• 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.
• Builds a high-performance quality culture with the Cell Therapy Vector and External Manufacturing Operations (VExMQ) organization.
• Recruits and develops global talent to sustain local and global competitiveness.

Responsibilities

Manage a team of Quality Senior Directors or others in the oversight of the External Manufacturing Network.

• Builds strong organizational capability for current and future needs.
• Recruit and develop global talent to sustain local and global competitiveness.
• Prepare and manage VExMQ organizational budget.
• Ensure 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.
• Deploy 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.
• Manage/support the resolution of quality and technical problems in alignment with global standards.
• Support audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs.
• Affirm 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 follow-up on resulting measures.
• Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS.
• Coordinate and/or provide SME input to for BMS Policies, Directives, SOPs related to quality compliance when required.
• Lead communication and develops effective strategies & partnership with stakeholders from MSQ, OPEX, Supply Chain, Regulatory, Project Management, and Operations.
• Ensure improved oversight of onboarding and offboarding in the fast changing Life Cycle Management of CT products.
• Ability to travel up to 25% (Domestic US and International).

Qualifications

• Specific Knowledge, Skills, Abilities:
  • Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
  • Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the whole.
  • Influencing and negotiating experience and capabilities in a matrix environment.
  • Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
  • Uses judgment to make sound decisions based on information gathered and analyzed.
  • Adapts to changing work environments, work priorities and organizational needs.
  • Pays close attention to detail, accuracy, and completeness.
  • Has a proven track record of delivering results and is action oriented.
• Minimum bachelor’s degree in science or pharmaceutical related fields (Chem, Pham, Bio, Chem Eng). Advanced degree preferred.
• Mastery of global Quality compliance processes and regulations, e.g., cGMP/GDP regulations for External Manufacturing QA.
• A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.
• A thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, sterility assurance, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.
• 15 years of experience managing Quality and Compliance organizations.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits Include Paid Time Off.