Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA
Bristol Myers Squibb
August 18, 2026
Remote friendly (Devens, MA)
United States
Operations
Senior Specialist, QA Investigations (Devens Cell Therapy Facility)
Responsibilities:
- Review and approve investigations / CAPAs / effectiveness checks for the manufacturing site (materials, manufacturing, laboratory, facility, computer systems).
- Author, review, and approve technical reports (e.g., risk assessments, deviation system monitoring reports) to support the deviations program.
- Ensure corrective/preventive actions are robust and adequately address root cause.
- Perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
- Identify improvement opportunities and support site/team continuous improvement goals and projects.
- Support internal and external inspections as required.
- Maintain compliance with assigned learning plan; support development and delivery of training content to cross-functional teams.
- Lead meetings, represent the function at cross-functional meetings, share data/knowledge, and build strong relationships with partner functions.
Knowledge, Skills, Abilities:
- Apply internal policies and regulatory guidelines.
- Proficient with computer tools (e.g., MS Office, Smartsheet) and ability to learn new software.
- Interpret data/results; assess and provide feedback on CAPAs.
- Critically review investigation reports; challenge technical conclusions using quality risk management principles.
- Excellent verbal and technical writing; present technical data clearly.
- Work in fast-paced environments with changing priorities; detail oriented; meet deadlines.
- Collaborate across teams; self-motivated; solve problems and recognize quality issues.
- Curious, critical thinking; innovative solutions.
Minimum Requirements:
- STEM bachelor’s preferred; high school diploma/Associate degree with equivalent education and experience considered.
- 4+ years in a regulated industry with 1+ year deviation experience; FDA/EMA experience in biopharma/cell therapy manufacturing preferred.
- Demonstrated experience with electronic systems and databases.
- Root cause analysis tools experience (e.g., 5-Why, human error prevention, Ishikawa/Fishbone, process flow diagrams).
Responsibilities:
- Review and approve investigations / CAPAs / effectiveness checks for the manufacturing site (materials, manufacturing, laboratory, facility, computer systems).
- Author, review, and approve technical reports (e.g., risk assessments, deviation system monitoring reports) to support the deviations program.
- Ensure corrective/preventive actions are robust and adequately address root cause.
- Perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
- Identify improvement opportunities and support site/team continuous improvement goals and projects.
- Support internal and external inspections as required.
- Maintain compliance with assigned learning plan; support development and delivery of training content to cross-functional teams.
- Lead meetings, represent the function at cross-functional meetings, share data/knowledge, and build strong relationships with partner functions.
Knowledge, Skills, Abilities:
- Apply internal policies and regulatory guidelines.
- Proficient with computer tools (e.g., MS Office, Smartsheet) and ability to learn new software.
- Interpret data/results; assess and provide feedback on CAPAs.
- Critically review investigation reports; challenge technical conclusions using quality risk management principles.
- Excellent verbal and technical writing; present technical data clearly.
- Work in fast-paced environments with changing priorities; detail oriented; meet deadlines.
- Collaborate across teams; self-motivated; solve problems and recognize quality issues.
- Curious, critical thinking; innovative solutions.
Minimum Requirements:
- STEM bachelor’s preferred; high school diploma/Associate degree with equivalent education and experience considered.
- 4+ years in a regulated industry with 1+ year deviation experience; FDA/EMA experience in biopharma/cell therapy manufacturing preferred.
- Demonstrated experience with electronic systems and databases.
- Root cause analysis tools experience (e.g., 5-Why, human error prevention, Ishikawa/Fishbone, process flow diagrams).