Sr. Director, External Manufacturing Quality, Cell Therapy
Bristol Myers Squibb
5 months ago
Remote friendly (Madison, NJ)
United States
Operations
Position Summary
- Define and shape Quality strategy and governance for Cell Therapy External Manufacturing (ExM) covering global Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTLs), ensuring cGMP compliance and safety/efficacy/quality of externally manufactured commercial products.
- Lead oversight of the External Manufacturing Network; build senior leadership relationships to support Virtual Plant Teams (VPTs)/Virtual Analytical Teams (VATs) and improve CMO Quality performance via risk-based oversight and periodic reviews.
Duties/Responsibilities
- Support Quality strategy and planning for Cell Therapy External Manufacturing and Quality Global Business.
- Own the Cell Therapy External Manufacturing Quality team strategy; ensure Quality Management of external suppliers/CMOs is executed, reported, and assessed.
- Develop a high-performance quality culture; build organizational capability (recruit/develop talent; succession-oriented mentoring/enrichment).
- Ensure Quality Assurance Agreements are created/maintained per GMP; manage resolution of quality/technical problems.
- Apply Quality Risk Management; support audits and Health Authority inspections (responses/CAPAs); ensure escalation and timely resolution of critical/major issues.
- Conduct quality governance via management reviews of KPIs/metrics; track and action GMP follow-ups.
- Provide oversight/resourcing for key ExM projects (transfers, launches, due diligence); coordinate SME input to policies/SOPs; lead stakeholder communications.
- Ensure improved onboarding/offboarding oversight for CT life cycle management; travel up to 25%.
Qualifications
- Communication/interpersonal skills across all stakeholder levels.
- Strategic, high business acumen; sound judgment; influence/negotiation in matrix environments.
- Build trusted relationships; lead large/complex programs; deliver results; set/maintain high standards.
- Bachelor’s degree in science/pharma field (Chem/Pharm/Bio/Chem Eng); advanced degree preferred.
- Mastery of global quality compliance (cGMP/GDP) for External Manufacturing QA; strong understanding of regulatory requirements and product quality investigations.
- Technical knowledge: pharmaceutical/biological manufacturing, sterility assurance, analyses, microbiology, statistical methods, QC/QA processes.
- 15+ years managing Quality and Compliance organizations.
Compensation (if applicable)
- Starting base ranges listed by location (Devens, MA and Madison, NJ); additional incentive cash/stock may be available.
Application instruction
- Apply even if your experience doesn’t perfectly match.
- Define and shape Quality strategy and governance for Cell Therapy External Manufacturing (ExM) covering global Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTLs), ensuring cGMP compliance and safety/efficacy/quality of externally manufactured commercial products.
- Lead oversight of the External Manufacturing Network; build senior leadership relationships to support Virtual Plant Teams (VPTs)/Virtual Analytical Teams (VATs) and improve CMO Quality performance via risk-based oversight and periodic reviews.
Duties/Responsibilities
- Support Quality strategy and planning for Cell Therapy External Manufacturing and Quality Global Business.
- Own the Cell Therapy External Manufacturing Quality team strategy; ensure Quality Management of external suppliers/CMOs is executed, reported, and assessed.
- Develop a high-performance quality culture; build organizational capability (recruit/develop talent; succession-oriented mentoring/enrichment).
- Ensure Quality Assurance Agreements are created/maintained per GMP; manage resolution of quality/technical problems.
- Apply Quality Risk Management; support audits and Health Authority inspections (responses/CAPAs); ensure escalation and timely resolution of critical/major issues.
- Conduct quality governance via management reviews of KPIs/metrics; track and action GMP follow-ups.
- Provide oversight/resourcing for key ExM projects (transfers, launches, due diligence); coordinate SME input to policies/SOPs; lead stakeholder communications.
- Ensure improved onboarding/offboarding oversight for CT life cycle management; travel up to 25%.
Qualifications
- Communication/interpersonal skills across all stakeholder levels.
- Strategic, high business acumen; sound judgment; influence/negotiation in matrix environments.
- Build trusted relationships; lead large/complex programs; deliver results; set/maintain high standards.
- Bachelor’s degree in science/pharma field (Chem/Pharm/Bio/Chem Eng); advanced degree preferred.
- Mastery of global quality compliance (cGMP/GDP) for External Manufacturing QA; strong understanding of regulatory requirements and product quality investigations.
- Technical knowledge: pharmaceutical/biological manufacturing, sterility assurance, analyses, microbiology, statistical methods, QC/QA processes.
- 15+ years managing Quality and Compliance organizations.
Compensation (if applicable)
- Starting base ranges listed by location (Devens, MA and Madison, NJ); additional incentive cash/stock may be available.
Application instruction
- Apply even if your experience doesn’t perfectly match.