QA Investigations & CAPA Manager

Bristol-Myers Squibb Company; Summit (NJ); On-site; USD 94,000 - 114,000; Full time

Job summary

Bristol Myers Squibb is seeking a Manager - QA Investigations at our Summit, NJ facility. This role provides quality oversight of deviation investigations, CAPAs, and effectiveness checks across manufacturing, ensuring compliance with FDA/EMA guidance and company policies.

You will lead investigations, review technical reports, coach staff, support inspections, and drive continual improvement while coordinating with global teams. A STEM degree and 6+ years in regulated biopharma are required.

Qualifications

• Bachelor's degree in STEM; high school/Associates with equivalent exp considered.
• 6+ years in a regulated industry; 2+ years deviation exp preferred.
• Experience with FDA/EMA regulations in biopharma or cell therapy.
• Proficient with root cause analysis tools (5-Why, Ishikawa, etc.).

Responsibilities

• Review and approve investigations, CAPAs, and effectiveness checks across manufacturing areas.
• Author/review technical reports including risk assessments and deviation monitoring.
• Ensure robust corrective actions addressing root causes.
• Coach staff on deviations/investigations and lead cross-functional meetings.
• Support inspections and training content delivery.

Skills

Regulatory guidelines

Technical writing

Root cause analysis

Data interpretation

MS Office & Smartsheets

Cross-functional collaboration

Quality systems knowledge

Problem solving

Education

Bachelor's degree in STEM

Job description

Bristol Myers Squibb is seeking a Manager - QA Investigations at our Summit, NJ facility. This role provides quality oversight of deviation investigations, CAPAs, and effectiveness checks across manufacturing, ensuring compliance with FDA/EMA guidance and company policies.

You will lead investigations, review technical reports, coach staff, support inspections, and drive continual improvement while coordinating with global teams. A STEM degree and 6+ years in regulated biopharma are required.