Sr. Manager - QA Ops, Investigations

About the role

Working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

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.

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.

Qualifications

• 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.

Pay

The starting compensation range for this role is $133,660 - $161,968. Additional incentive cash and stock opportunities may be available.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 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.
• Work-life Benefits: Paid Time Off, flexible time off, 11 paid national holidays, and 3 optional holidays.

Schedule

This role is site-essential, requiring 100% of shifts onsite at the assigned facility.