Manager, Quality Assurance Investigations, Cell Therapy, Devens - MA
Bristol Myers Squibb
5 hours ago
On-site
Devens, MA
Operations
Position Summary
Manager, Quality Assurance Investigations—Devens Cell Therapy Facility. Provide quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records for manufactured products, in compliance with applicable regulations and BMS policies.
Key Responsibilities
- Review/approve complex investigations, CAPAs, and effectiveness checks across manufacturing, laboratory, facility, utility, and incoming processes.
- Author/review/approve technical reports (e.g., risk assessments, deviation system monitoring reports).
- Ensure CAPAs are robust and address root cause.
- Analyze deviation/quality metrics to support timely closure and disposition timelines.
- Drive deployment of effective deviation processes; coach employees on investigations.
- Resolve investigational process/system issues; cascade issues to global team; monitor deviation metrics.
- Lead continuous improvement; support internal/external inspections and present audit topics as needed.
- Maintain compliance with assigned learning plan; support training content and integration of newer team members.
- Act as SME for root cause analysis/investigations and guide less experienced staff; lead cross-functional/network meetings.
Qualifications & Skills
- Ability to interpret/apply internal policies and regulatory guidelines.
- Proficient with MS Office and tools such as Smartsheet; learn new software.
- Interpret complex data; critically assess/challenge CAPAs and investigation conclusions.
- Strong verbal/technical writing; present technical data clearly.
- Fast-paced, strategic, deadline-driven; independent across functions; motivate/foster positive team.
- Root cause analysis tools: 5-Why, human error prevention, Ishikawa (fishbone), process flow diagram.
Education/Experience
- STEM bachelor preferred (or HS diploma/associate with equivalent experience).
- 6+ years in regulated industry; preferably 2+ years deviation experience; FDA/EMA biopharma or cell therapy experience preferred.
Compensation/Benefits (explicitly stated)
- Devens, MA: $100,480–$121,756.
- Health, wellbeing, financial protection (incl. 401(k), life/disability), and paid time off (details by employment location/type).
Manager, Quality Assurance Investigations—Devens Cell Therapy Facility. Provide quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records for manufactured products, in compliance with applicable regulations and BMS policies.
Key Responsibilities
- Review/approve complex investigations, CAPAs, and effectiveness checks across manufacturing, laboratory, facility, utility, and incoming processes.
- Author/review/approve technical reports (e.g., risk assessments, deviation system monitoring reports).
- Ensure CAPAs are robust and address root cause.
- Analyze deviation/quality metrics to support timely closure and disposition timelines.
- Drive deployment of effective deviation processes; coach employees on investigations.
- Resolve investigational process/system issues; cascade issues to global team; monitor deviation metrics.
- Lead continuous improvement; support internal/external inspections and present audit topics as needed.
- Maintain compliance with assigned learning plan; support training content and integration of newer team members.
- Act as SME for root cause analysis/investigations and guide less experienced staff; lead cross-functional/network meetings.
Qualifications & Skills
- Ability to interpret/apply internal policies and regulatory guidelines.
- Proficient with MS Office and tools such as Smartsheet; learn new software.
- Interpret complex data; critically assess/challenge CAPAs and investigation conclusions.
- Strong verbal/technical writing; present technical data clearly.
- Fast-paced, strategic, deadline-driven; independent across functions; motivate/foster positive team.
- Root cause analysis tools: 5-Why, human error prevention, Ishikawa (fishbone), process flow diagram.
Education/Experience
- STEM bachelor preferred (or HS diploma/associate with equivalent experience).
- 6+ years in regulated industry; preferably 2+ years deviation experience; FDA/EMA biopharma or cell therapy experience preferred.
Compensation/Benefits (explicitly stated)
- Devens, MA: $100,480–$121,756.
- Health, wellbeing, financial protection (incl. 401(k), life/disability), and paid time off (details by employment location/type).