Sr. Manager - QA Ops, Investigations

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The Sr. Manager, Quality Operations (Investigations) leads a dedicated team overseeing deviation management activities in support of Cell Therapy manufacturing at the Bothell site. This role provides comprehensive quality oversight of Deviation Management and CAPA workflows, ensuring all events across Minor, Major, and Critical deviation classifications are thoroughly reviewed and appropriately approved in alignment with regulatory standards and site procedures.

• Oversee and mentor a team of individual contributors responsible for the review, investigation, and approval of Deviations and CAPA records.
• Champion quality principles by leading trend investigations, driving continuous improvement initiatives, and executing projects that advance Deviation and CAPA Management processes.
• Provide leadership support for critical site initiatives including Right First Time (RFT), the Trending Program, Deviation Reduction work streams, and coordination of Integrated Health Hazard Assessments (IHHAs).
• Support personnel hiring and development, ensure effective onboarding and training for new hires, and foster a culture of accountability and high-quality performance.
• Liaise with the broader BMS Network to implement harmonized practices across sites and serve as Local Process Owner (LPO) for Deviations.
• Partner cross-functionally to ensure robust impact assessments, root cause evaluations, and timely implementation of corrective and preventive actions.
• Collaborate actively with the Quality Shop Floor function to drive engagement and advance quality and risk maturity across the QA Ops team.
• Maintain a strong, visible presence within QA Operations, setting the standard for quality excellence and regulatory compliance across the organization.

• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree or equivalent combination of education and experience is acceptable.
• Minimum 6 years of progressive GxP experience in biotechnology or pharmaceutical manufacturing, with preferred focus on biologics or cell therapy.
• Minimum of 3 years of hands‑on experience managing deviation and CAPA records within quality systems.
• Minimum 3 years of leadership experience, including direct supervision and development of team members.
• Solid knowledge of FDA and EMA regulations governing pharmaceutical and biotechnology operations.
• Proficiency in advanced Root Cause Analysis (RCA) tools and methodologies.
• Experience applying Quality Risk Management principles to support robust decision‑making.

Bothell - WA - US: $133,660 - $161,968

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis.

Additional incentive cash and stock opportunities (based on eligibility) may be available.

The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience.

Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location.

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