Senior Director, Product Quality Engineering

Senior Director of Cell Therapy Product Quality Engineering

Reports to Executive Director, Cell Therapy Global Product Quality

• 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.

• 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.

• 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.

• 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).

Apply even if your experience doesn’t perfectly match the requirements.