Head of QA Technical Operations
Bristol Myers Squibb
5 months ago
On-site
Summit, NJ
Operations
Duties and Responsibilities:
- Lead QA oversight of cGMP deviations, CAPAs, Change Controls, and qualification/validation at the Summit, NJ Cell Therapy manufacturing facility (S12); ensure adherence to applicable cGMP regulations and BMS policies.
- Direct planned/unplanned deviation response across Operations, Facilities, QC, and QA; ensure containment, support deviation strategy/documentation, approve deviations, support CAPA identification, and drive site awareness/retraining.
- Lead site-wide QA transformational programs to reduce deviations, improve “right first time,” quality record timeliness, identify/remediate trends, improve turnaround time (TAT), and prevent issues.
- Ensure timely approval of GMP documentation, risk assessments, and change control impact assessments.
- Ensure systems/processes/resources enable compliant CAR T manufacturing.
- Serve as primary Delegate of Authority (DOA) and proxy for Head of Quality, Cell Therapy Manufacturing; act as GMP subject matter expert during audits/inspections and support inspection readiness.
- Lead/develop QA team (hiring, mentoring, development) and manage annual operating budget.
Qualifications/Required Skills:
- Bachelor’s in Science or Engineering; 15+ years managing Quality Assurance (minimum 7 years people management).
- Expertise in GMP for Pharmaceutical/Biotech/ATMP manufacturing; experience implementing/overseeing GMP in clinical/commercial manufacturing plants (required).
- Strong communication, cross-functional partnership, strategic thinking, influencing/negotiation in matrix environments, leadership, and decision-making; strong written/verbal and presentation/visual management.
- Expert-level Pharmaceutical Quality Management, Project Management and/or Lean Six Sigma (strongly preferred).
- Preferred: Biologics/Cell Therapy manufacturing background.
Travel: Up to 10%.
Benefits (explicitly listed): Health coverage; wellbeing programs; 401(k) and other insurance/protection benefits; Paid Time Off (includes flexible time off/paid holidays per employee category) and other eligible time off options.
- Lead QA oversight of cGMP deviations, CAPAs, Change Controls, and qualification/validation at the Summit, NJ Cell Therapy manufacturing facility (S12); ensure adherence to applicable cGMP regulations and BMS policies.
- Direct planned/unplanned deviation response across Operations, Facilities, QC, and QA; ensure containment, support deviation strategy/documentation, approve deviations, support CAPA identification, and drive site awareness/retraining.
- Lead site-wide QA transformational programs to reduce deviations, improve “right first time,” quality record timeliness, identify/remediate trends, improve turnaround time (TAT), and prevent issues.
- Ensure timely approval of GMP documentation, risk assessments, and change control impact assessments.
- Ensure systems/processes/resources enable compliant CAR T manufacturing.
- Serve as primary Delegate of Authority (DOA) and proxy for Head of Quality, Cell Therapy Manufacturing; act as GMP subject matter expert during audits/inspections and support inspection readiness.
- Lead/develop QA team (hiring, mentoring, development) and manage annual operating budget.
Qualifications/Required Skills:
- Bachelor’s in Science or Engineering; 15+ years managing Quality Assurance (minimum 7 years people management).
- Expertise in GMP for Pharmaceutical/Biotech/ATMP manufacturing; experience implementing/overseeing GMP in clinical/commercial manufacturing plants (required).
- Strong communication, cross-functional partnership, strategic thinking, influencing/negotiation in matrix environments, leadership, and decision-making; strong written/verbal and presentation/visual management.
- Expert-level Pharmaceutical Quality Management, Project Management and/or Lean Six Sigma (strongly preferred).
- Preferred: Biologics/Cell Therapy manufacturing background.
Travel: Up to 10%.
Benefits (explicitly listed): Health coverage; wellbeing programs; 401(k) and other insurance/protection benefits; Paid Time Off (includes flexible time off/paid holidays per employee category) and other eligible time off options.