Sr. Manager - QA Ops, Investigations

Bristol Myers Squibb•Bothell, WA

1d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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 workstreams, 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.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval, 11 paid national holidays) for US Exempt Employees.
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time.
Up to 2 paid volunteer days per year.
Summer hours flexibility.
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.