Senior QA Investigations Specialist – Deviations & CAPA

Bristol-Myers Squibb; Massachusetts; On-site; USD 90,000 - 109,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Job summary

Bristol Myers Squibb in Devens, MA, seeks a Senior Specialist, QA Investigations to provide QA oversight of deviation investigations, CAPAs, and effectiveness checks at the cell therapy facility, ensuring compliance with FDA/EMA and BMS standards.

You will review investigations, author reports, lead root-cause analysis, and support inspections; collaborate across manufacturing, quality, and facilities; drive timely closure of quality events and continuous improvement.

Qualifications

• Bachelor's degree in STEM; 4+ years in a regulated industry.
• 1+ year deviation experience; FDA/EMA regulation experience in biopharma or cell therapy preferred.
• Experience with electronic systems and databases; root cause analysis tools.

Responsibilities

• Review and approve investigations/CAPAs/effectiveness checks across manufacturing site.
• Author/review technical reports, including risk assessments and deviation-system monitoring reports.
• Ensure robust corrective/preventive actions addressing root cause.
• Perform routine reporting/analysis of metrics to ensure timely closure of quality events.
• Support internal/external inspections as required.
• Maintain learning plans and deliver training content to cross-functional teams.
• Lead meetings and represent function in cross-functional forums.

Skills

Regulatory interpretation

Data interpretation

CAPA analysis

Technical writing

Cross-functional work

Quality risk mgmt

MS Office skills

Attention to detail

Decision making

Education

Bachelor's degree in STEM field

Tools

Electronic systems & databases

5-Why analysis

Ishikawa Diagram

Process Flow Diagrams

Job description

Bristol Myers Squibb in Devens, MA, seeks a Senior Specialist, QA Investigations to provide QA oversight of deviation investigations, CAPAs, and effectiveness checks at the cell therapy facility, ensuring compliance with FDA/EMA and BMS standards.

You will review investigations, author reports, lead root-cause analysis, and support inspections; collaborate across manufacturing, quality, and facilities; drive timely closure of quality events and continuous improvement.