Senior Director, Product Quality Engineering
Bristol Myers Squibb
8 days ago
Remote friendly (Devens, MA)
United States
Operations
Position Summary
Senior Director, Cell Therapy Product Quality Engineering: Lead global team to ensure cGMP compliance, product quality, and regulatory readiness for cell therapy at BMS.
Key Responsibilities
- Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across sites/programs.
- Lead a global matrix team of product quality experts (influence without direct authority) to align across products.
- Drive lifecycle platform strategies (ICS, Stability, analytical lifecycle management, jurisdictional control/specification strategy).
- Harmonize PQRA methodologies and robustness metrics across programs.
- Ensure harmonized processes meet global regulatory requirements and inspection readiness.
- Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed standards into workflows.
- Foster innovation/agility/collaboration/inclusion while maintaining compliance/quality mindset.
- Establish and meet quality performance/compliance metrics aligned to business/financial objectives.
- Lead governance meetings (steering committees/partner collaborations) for proactive quality management.
Basic Qualifications
- BS/MS/PhD in Life Sciences (Biology, Chemistry, Engineering) or related; 12–15+ years GMP Quality; 7+ years people management; 5+ years cell therapy/gene therapy/advanced biologics manufacturing.
- Experience leading global quality teams in matrix environments.
- Deep cGMP, regulatory, and quality systems knowledge for cell/gene therapy manufacturing.
- Strategic thinker with strong analytical/problem-solving/decision-making.
- Excellent written/verbal communication across all levels and external partners.
- Experience with technical transfers, process qualification, comparability, and validation for new technologies.
- Ability to balance agility with robust compliance/quality oversight.
- Experience driving continuous improvement and digitization in quality operations.
Preferred Qualifications
- Autologous CAR T, viral vector manufacturing, and QC automation.
- Product Quality leadership in cell/gene therapy.
- Track record supporting product launches, BLA submissions, and regulatory interactions.
- Combination of QA/QC/compliance experience for process development/MS&T/external manufacturing.
Compensation & Benefits (as stated)
- Compensation ranges (FTE): $223,640–$298,092 depending on location.
- Benefits include health coverage; wellbeing support; 401(k), disability/life insurance, and other listed protections; paid time off (varies by employee type), plus eligibility-based additional time off (e.g., Global Shutdown).
Work Arrangement (as stated)
- Site-essential: 100% onsite. Site-by-design: hybrid with at least 50% onsite.
Application Instructions
- If the role interests you but your resume isn’t a perfect match, apply anyway.
Senior Director, Cell Therapy Product Quality Engineering: Lead global team to ensure cGMP compliance, product quality, and regulatory readiness for cell therapy at BMS.
Key Responsibilities
- Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across sites/programs.
- Lead a global matrix team of product quality experts (influence without direct authority) to align across products.
- Drive lifecycle platform strategies (ICS, Stability, analytical lifecycle management, jurisdictional control/specification strategy).
- Harmonize PQRA methodologies and robustness metrics across programs.
- Ensure harmonized processes meet global regulatory requirements and inspection readiness.
- Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed standards into workflows.
- Foster innovation/agility/collaboration/inclusion while maintaining compliance/quality mindset.
- Establish and meet quality performance/compliance metrics aligned to business/financial objectives.
- Lead governance meetings (steering committees/partner collaborations) for proactive quality management.
Basic Qualifications
- BS/MS/PhD in Life Sciences (Biology, Chemistry, Engineering) or related; 12–15+ years GMP Quality; 7+ years people management; 5+ years cell therapy/gene therapy/advanced biologics manufacturing.
- Experience leading global quality teams in matrix environments.
- Deep cGMP, regulatory, and quality systems knowledge for cell/gene therapy manufacturing.
- Strategic thinker with strong analytical/problem-solving/decision-making.
- Excellent written/verbal communication across all levels and external partners.
- Experience with technical transfers, process qualification, comparability, and validation for new technologies.
- Ability to balance agility with robust compliance/quality oversight.
- Experience driving continuous improvement and digitization in quality operations.
Preferred Qualifications
- Autologous CAR T, viral vector manufacturing, and QC automation.
- Product Quality leadership in cell/gene therapy.
- Track record supporting product launches, BLA submissions, and regulatory interactions.
- Combination of QA/QC/compliance experience for process development/MS&T/external manufacturing.
Compensation & Benefits (as stated)
- Compensation ranges (FTE): $223,640–$298,092 depending on location.
- Benefits include health coverage; wellbeing support; 401(k), disability/life insurance, and other listed protections; paid time off (varies by employee type), plus eligibility-based additional time off (e.g., Global Shutdown).
Work Arrangement (as stated)
- Site-essential: 100% onsite. Site-by-design: hybrid with at least 50% onsite.
Application Instructions
- If the role interests you but your resume isn’t a perfect match, apply anyway.