Manager, Quality Systems - Change Control and Quality Risk Management
Bristol Myers Squibb
June 24, 2026
Remote friendly (Devens, MA)
United States
Operations
Position Summary
The Manager Quality Systems - Change Control and Quality Risk Management (QRM) supports ownership and oversight of assigned quality systems per local and global standards, ensuring compliance and performance of Change Control and QRM processes at the site level, including periodic process performance assessments and continuous improvement.
Responsibilities
- Oversee the Devens Cell Therapy Change Control system, including facilitation of the Change Control Review Board.
- Drive Change Control governance maturity via data analysis and management review integration through the site Quality Council.
- Administer/maintain the site change control system consistent with standards and applicable health authority regulations.
- Liaise with Technical Review Board, IT change management, and QA Technical Services for technical change management solutions.
- Lead compliance-focused problem solving through stakeholder management; maintain strong partner relationships.
- Serve as site SME for relevant quality systems and own site SOPs/Work Instructions/Training and business process tools.
- Oversee site QRM systems, including maintenance of the Quality Risk Register.
- Function as Site Risk Champion as needed; facilitate risk assessments and risk reduction initiatives.
- Support internal/external inspections as site SME.
Qualifications (Skills/Knowledge/Experience)
- Tech Transfer, Computer System Validation, Commissioning and Qualification.
- Risk management tools/methods (e.g., FMEA, PHA, HACCP, risk ranking/filtering).
- Interpret/apply internal policies and regulatory guidelines; strong data interpretation.
- Excellent technical writing and ability to present complex data.
- 6+ years in a regulated industry; 2+ years quality systems experience with Change Control and Risk Management (FDA/EMA biopharma/cell therapy preferred).
- STEM bachelor’s preferred; electronic systems/database proficiency.
Benefits (selected)
- Health coverage; wellbeing support; 401(k), disability and life/accident insurance.
- Paid time off (flexible time off for US exempt; or 160 hours annual paid vacation for specified roles).
Application instruction
If the role intrigues you but doesn’t perfectly match your resume, apply anyway.
The Manager Quality Systems - Change Control and Quality Risk Management (QRM) supports ownership and oversight of assigned quality systems per local and global standards, ensuring compliance and performance of Change Control and QRM processes at the site level, including periodic process performance assessments and continuous improvement.
Responsibilities
- Oversee the Devens Cell Therapy Change Control system, including facilitation of the Change Control Review Board.
- Drive Change Control governance maturity via data analysis and management review integration through the site Quality Council.
- Administer/maintain the site change control system consistent with standards and applicable health authority regulations.
- Liaise with Technical Review Board, IT change management, and QA Technical Services for technical change management solutions.
- Lead compliance-focused problem solving through stakeholder management; maintain strong partner relationships.
- Serve as site SME for relevant quality systems and own site SOPs/Work Instructions/Training and business process tools.
- Oversee site QRM systems, including maintenance of the Quality Risk Register.
- Function as Site Risk Champion as needed; facilitate risk assessments and risk reduction initiatives.
- Support internal/external inspections as site SME.
Qualifications (Skills/Knowledge/Experience)
- Tech Transfer, Computer System Validation, Commissioning and Qualification.
- Risk management tools/methods (e.g., FMEA, PHA, HACCP, risk ranking/filtering).
- Interpret/apply internal policies and regulatory guidelines; strong data interpretation.
- Excellent technical writing and ability to present complex data.
- 6+ years in a regulated industry; 2+ years quality systems experience with Change Control and Risk Management (FDA/EMA biopharma/cell therapy preferred).
- STEM bachelor’s preferred; electronic systems/database proficiency.
Benefits (selected)
- Health coverage; wellbeing support; 401(k), disability and life/accident insurance.
- Paid time off (flexible time off for US exempt; or 160 hours annual paid vacation for specified roles).
Application instruction
If the role intrigues you but doesn’t perfectly match your resume, apply anyway.