Sr. Manager - QA Ops, Investigations
Bristol Myers Squibb
August 22, 2026
Remote friendly (Bothell, WA)
United States
Operations
Position Summary
Sr. Manager, Quality Operations (Investigations) leads a team overseeing deviation management activities in support of Cell Therapy manufacturing at the Bothell site. Provides quality oversight of Deviation Management and CAPA workflows, ensuring Minor, Major, and Critical deviation events are reviewed and appropriately approved per regulatory standards and site procedures.
Key Responsibilities
- Oversee and mentor a team reviewing, investigating, and approving Deviations and CAPA records.
- Lead trend investigations, continuous improvement initiatives, and projects advancing Deviation and CAPA Management processes.
- Support critical site initiatives: Right First Time (RFT), Trending Program, Deviation Reduction workstreams, and coordination of Integrated Health Hazard Assessments (IHHAs).
- Support hiring and development; ensure onboarding and training; foster accountability and high-quality performance.
- Liaise with the BMS Network for harmonized site practices; serve as Local Process Owner (LPO) for Deviations.
- Partner cross-functionally for impact assessments, root cause evaluations, and timely corrective and preventive actions (CAPA).
- Collaborate with Quality Shop Floor to advance quality and risk maturity across QA Ops.
- Maintain a visible QA Operations presence to set standards for quality excellence and regulatory compliance.
Qualifications
- Bachelor’s in relevant scientific/engineering discipline; advanced degree or equivalent accepted.
- 6+ years progressive GxP experience in biotech/pharma manufacturing (preferred biologics/cell therapy); 3+ years hands-on deviation and CAPA management in quality systems.
- 3+ years leadership experience with direct supervision and development.
- Knowledge of FDA and EMA regulations.
- Proficiency in advanced Root Cause Analysis (RCA) tools/methodologies.
- Experience applying Quality Risk Management principles.
Benefits (explicitly listed)
- Health Coverage (medical, pharmacy, dental, vision); Wellbeing Support; 401(k), disability, life insurance, and other specified protection benefits.
- Paid Time Off (includes flexible time off/unlimited for US Exempt; annual paid vacation for certain locations/employee types), plus national holidays and additional eligible leave.
Compensation
Bothell, WA, US: $133,660–$161,968 (full-time; additional incentives may be available).
Sr. Manager, Quality Operations (Investigations) leads a team overseeing deviation management activities in support of Cell Therapy manufacturing at the Bothell site. Provides quality oversight of Deviation Management and CAPA workflows, ensuring Minor, Major, and Critical deviation events are reviewed and appropriately approved per regulatory standards and site procedures.
Key Responsibilities
- Oversee and mentor a team reviewing, investigating, and approving Deviations and CAPA records.
- Lead trend investigations, continuous improvement initiatives, and projects advancing Deviation and CAPA Management processes.
- Support critical site initiatives: Right First Time (RFT), Trending Program, Deviation Reduction workstreams, and coordination of Integrated Health Hazard Assessments (IHHAs).
- Support hiring and development; ensure onboarding and training; foster accountability and high-quality performance.
- Liaise with the BMS Network for harmonized site practices; serve as Local Process Owner (LPO) for Deviations.
- Partner cross-functionally for impact assessments, root cause evaluations, and timely corrective and preventive actions (CAPA).
- Collaborate with Quality Shop Floor to advance quality and risk maturity across QA Ops.
- Maintain a visible QA Operations presence to set standards for quality excellence and regulatory compliance.
Qualifications
- Bachelor’s in relevant scientific/engineering discipline; advanced degree or equivalent accepted.
- 6+ years progressive GxP experience in biotech/pharma manufacturing (preferred biologics/cell therapy); 3+ years hands-on deviation and CAPA management in quality systems.
- 3+ years leadership experience with direct supervision and development.
- Knowledge of FDA and EMA regulations.
- Proficiency in advanced Root Cause Analysis (RCA) tools/methodologies.
- Experience applying Quality Risk Management principles.
Benefits (explicitly listed)
- Health Coverage (medical, pharmacy, dental, vision); Wellbeing Support; 401(k), disability, life insurance, and other specified protection benefits.
- Paid Time Off (includes flexible time off/unlimited for US Exempt; annual paid vacation for certain locations/employee types), plus national holidays and additional eligible leave.
Compensation
Bothell, WA, US: $133,660–$161,968 (full-time; additional incentives may be available).