Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA
Bristol Myers Squibb
August 15, 2026
Remote friendly (Devens, MA)
United States
Operations
Senior Specialist, QA Investigations (Cell Therapy, Devens, MA)
Responsibilities:
- Review and approve deviation investigations/CAPAs/effectiveness checks for the manufacturing site (materials, manufacturing, lab, facility, computer systems).
- Author/review/approve technical reports (e.g., risk assessments, deviation system monitoring reports) for the deviations program.
- Ensure corrective/preventive actions robustly address root cause.
- Perform routine reporting/analysis of metrics to support timely closure of quality events/actions; identify improvement opportunities.
- Support internal and external inspections as required.
- Maintain compliance with assigned learning plan; support development/delivery of training content.
- Lead meetings; represent QA investigations in cross-functional meetings; share data/knowledge and build relationships.
Knowledge, Skills, Abilities:
- Interpret and apply internal policies and regulatory guidelines.
- Proficient with MS Office/Smartsheet and ability to learn new software.
- Interpret data/results; assess/provide feedback on CAPAs; critically review investigation conclusions per quality risk management.
- Excellent verbal and technical writing; present data to management.
- Fast-paced, changing priorities; detail-oriented, deadline-driven.
Minimum Requirements:
- STEM bachelor’s preferred; alternatively HS/AA plus equivalent experience.
- 4+ years in a regulated industry with 1+ year deviation experience (FDA/EMA in biopharma/cell therapy preferred).
- Electronic systems/database experience.
- Root-cause analysis tools (e.g., 5-Whys, human error prevention, Ishikawa/Fishbone).
Compensation & Benefits (high level):
- $89,780–$108,789 (Devens, MA, US).
- Health coverage, 401(k), life/disability, and Paid Time Off (flexible time off/annual vacation depending on location/role).
Application instruction:
- If the role doesn’t perfectly match your resume, apply anyway.
Responsibilities:
- Review and approve deviation investigations/CAPAs/effectiveness checks for the manufacturing site (materials, manufacturing, lab, facility, computer systems).
- Author/review/approve technical reports (e.g., risk assessments, deviation system monitoring reports) for the deviations program.
- Ensure corrective/preventive actions robustly address root cause.
- Perform routine reporting/analysis of metrics to support timely closure of quality events/actions; identify improvement opportunities.
- Support internal and external inspections as required.
- Maintain compliance with assigned learning plan; support development/delivery of training content.
- Lead meetings; represent QA investigations in cross-functional meetings; share data/knowledge and build relationships.
Knowledge, Skills, Abilities:
- Interpret and apply internal policies and regulatory guidelines.
- Proficient with MS Office/Smartsheet and ability to learn new software.
- Interpret data/results; assess/provide feedback on CAPAs; critically review investigation conclusions per quality risk management.
- Excellent verbal and technical writing; present data to management.
- Fast-paced, changing priorities; detail-oriented, deadline-driven.
Minimum Requirements:
- STEM bachelor’s preferred; alternatively HS/AA plus equivalent experience.
- 4+ years in a regulated industry with 1+ year deviation experience (FDA/EMA in biopharma/cell therapy preferred).
- Electronic systems/database experience.
- Root-cause analysis tools (e.g., 5-Whys, human error prevention, Ishikawa/Fishbone).
Compensation & Benefits (high level):
- $89,780–$108,789 (Devens, MA, US).
- Health coverage, 401(k), life/disability, and Paid Time Off (flexible time off/annual vacation depending on location/role).
Application instruction:
- If the role doesn’t perfectly match your resume, apply anyway.