Sr Manager QA Technical Operations
Bristol Myers Squibb
August 22, 2026
Remote friendly (Devens, MA)
United States
Operations
Principal Objective Of The Position
- Provide leadership to a team of Quality managers with oversight and support for Quality Control projects and daily activities.
- Manage and oversee operations for Cell Banking, Local Site Change Controls, QA for Technology Transfer, QA for Automation and QA for Validation, and QA for MS&T and Site Engineering Maintenance programs.
- May assist in preparing for and hosting regulatory and customer audits.
Major Duties and Responsibilities
- Directly supervise personnel approving change controls, protocols/reports, and investigations for validation and automation teams.
- Supervise personnel reviewing manufacturing maintenance, calibration, and scheduling programs.
- Oversee quality approval of technical transfer documentation (PPQ, PD, FFR, MBR, Formula Set, system Master Data).
- Interface in clinical and commercial tech transfer meetings; coordinate risk tracking/resolution with Quality Tech Transfer Lead and QA AD.
- Make and communicate minor tech transfer decisions/risks; track milestones for resource allocation.
- Represent quality in Tech Transfer Governance and project meetings; support approval of tech transfer risk assessments and updates.
- Collaborate with functional area managers on resourcing; review/approve site and department SOPs.
- Develop and manage direct-report training curriculum; support and participate in regulatory inspections and internal audits.
- Hire, integrate, and develop talent; support/approve complex operational investigations.
Knowledge and Skill / Qualifications / Required/Preferred
- B.S. (science/engineering/biochemistry or related) required.
- Minimum 5 years biopharmaceutical quality; plus 2–3 years increasing responsibility (and 8+ years biopharmaceutical operations with 2 years management desirable).
- Demonstrated quality/compliance leadership for commercial biologics; knowledge of biotech bulk/finished products and analytical testing highly desirable.
- Knowledge of US/EU cGMP; FDA/EMA/other regulatory experience.
- Leadership, communication, matrix leadership, and ability to influence cross-functionally.
- Business systems: SAP, LIMS, Maximo, Syncade, DeltaV, Veeva Vault (knowledge required).
Compensation Overview
- Devens, MA (US): $130,020–$157,559.
- Provide leadership to a team of Quality managers with oversight and support for Quality Control projects and daily activities.
- Manage and oversee operations for Cell Banking, Local Site Change Controls, QA for Technology Transfer, QA for Automation and QA for Validation, and QA for MS&T and Site Engineering Maintenance programs.
- May assist in preparing for and hosting regulatory and customer audits.
Major Duties and Responsibilities
- Directly supervise personnel approving change controls, protocols/reports, and investigations for validation and automation teams.
- Supervise personnel reviewing manufacturing maintenance, calibration, and scheduling programs.
- Oversee quality approval of technical transfer documentation (PPQ, PD, FFR, MBR, Formula Set, system Master Data).
- Interface in clinical and commercial tech transfer meetings; coordinate risk tracking/resolution with Quality Tech Transfer Lead and QA AD.
- Make and communicate minor tech transfer decisions/risks; track milestones for resource allocation.
- Represent quality in Tech Transfer Governance and project meetings; support approval of tech transfer risk assessments and updates.
- Collaborate with functional area managers on resourcing; review/approve site and department SOPs.
- Develop and manage direct-report training curriculum; support and participate in regulatory inspections and internal audits.
- Hire, integrate, and develop talent; support/approve complex operational investigations.
Knowledge and Skill / Qualifications / Required/Preferred
- B.S. (science/engineering/biochemistry or related) required.
- Minimum 5 years biopharmaceutical quality; plus 2–3 years increasing responsibility (and 8+ years biopharmaceutical operations with 2 years management desirable).
- Demonstrated quality/compliance leadership for commercial biologics; knowledge of biotech bulk/finished products and analytical testing highly desirable.
- Knowledge of US/EU cGMP; FDA/EMA/other regulatory experience.
- Leadership, communication, matrix leadership, and ability to influence cross-functionally.
- Business systems: SAP, LIMS, Maximo, Syncade, DeltaV, Veeva Vault (knowledge required).
Compensation Overview
- Devens, MA (US): $130,020–$157,559.