Senior Director, Product Quality Engineering
Bristol Myers Squibb
4 months ago
Remote friendly (Princeton, NJ)
United States
Operations
Senior Director of Cell Therapy Product Quality Engineering (Reports to Executive Director, Cell Therapy Global Product Quality)
Key Responsibilities:
- Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across all sites and programs.
- Lead a global matrix team of product quality experts to achieve alignment across products.
- Drive lifecycle platform strategies for Integrated Control Strategy (ICS), Stability, analytical lifecycle management, jurisdictional control and specification strategy.
- Harmonize product quality risk assessment (PQRA) methodologies and robustness metrics across programs.
- Ensure harmonized processes meet global regulatory requirements and support inspection readiness.
- Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed harmonized standards into operational workflows.
- Foster innovation, agility, collaboration, and inclusion while maintaining strong compliance/quality.
- Establish and meet quality performance and compliance metrics aligned to business/financial objectives.
- Lead internal/external governance (e.g., steering committees) 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 a matrix environment; hiring/coaching/developing technical talent.
- Deep cGMP, regulatory, and quality system knowledge for cell/gene therapy manufacturing.
- Strategic, analytical problem-solving/decision-making; strong written/verbal communication.
- Experience with technical transfers, process qualification, comparability, and validation for new manufacturing technologies.
- Ability to work fast-paced while maintaining compliance/quality; drive continuous improvement and quality digitization.
Preferred Qualifications:
- Autologous CAR T, viral vector manufacturing, and QC equipment/system automation.
- Product Quality leadership for cell or gene therapy.
- Experience supporting product launches, BLA submissions, and regulatory interactions.
- Combination experience across QA/QC/compliance for process development, MS&T, and external manufacturing.
Benefits (explicitly listed):
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs (BMS Well-Being Account, BMS Living Life Better, EAP); financial protection (401(k), disability, life/accident insurance, supplemental health, business travel protection, legal support, survivor support).
- Paid Time Off (including flexible time off and paid holidays depending on location/employee type).
Application Instructions:
- Apply even if your experience doesn’t perfectly match the requirements.
Key Responsibilities:
- Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across all sites and programs.
- Lead a global matrix team of product quality experts to achieve alignment across products.
- Drive lifecycle platform strategies for Integrated Control Strategy (ICS), Stability, analytical lifecycle management, jurisdictional control and specification strategy.
- Harmonize product quality risk assessment (PQRA) methodologies and robustness metrics across programs.
- Ensure harmonized processes meet global regulatory requirements and support inspection readiness.
- Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed harmonized standards into operational workflows.
- Foster innovation, agility, collaboration, and inclusion while maintaining strong compliance/quality.
- Establish and meet quality performance and compliance metrics aligned to business/financial objectives.
- Lead internal/external governance (e.g., steering committees) 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 a matrix environment; hiring/coaching/developing technical talent.
- Deep cGMP, regulatory, and quality system knowledge for cell/gene therapy manufacturing.
- Strategic, analytical problem-solving/decision-making; strong written/verbal communication.
- Experience with technical transfers, process qualification, comparability, and validation for new manufacturing technologies.
- Ability to work fast-paced while maintaining compliance/quality; drive continuous improvement and quality digitization.
Preferred Qualifications:
- Autologous CAR T, viral vector manufacturing, and QC equipment/system automation.
- Product Quality leadership for cell or gene therapy.
- Experience supporting product launches, BLA submissions, and regulatory interactions.
- Combination experience across QA/QC/compliance for process development, MS&T, and external manufacturing.
Benefits (explicitly listed):
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs (BMS Well-Being Account, BMS Living Life Better, EAP); financial protection (401(k), disability, life/accident insurance, supplemental health, business travel protection, legal support, survivor support).
- Paid Time Off (including flexible time off and paid holidays depending on location/employee type).
Application Instructions:
- Apply even if your experience doesn’t perfectly match the requirements.