Position SummaryThe 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.
Key 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.
Compensation Overview: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. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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 include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
