Sr. Manager - QA Ops, Investigations

Bristol-Myers Squibb; Bothell (WA); On-site; USD 134,000 - 162,000; Full time

Benefits offered by this job

Health coverage: Medical, pharmacy, 3–

Wellbeing programs

401(k) and financial protection

Paid time off

Job summary

Bristol Myers Squibb in Bothell, WA is seeking a Sr. Manager, Quality Operations (Investigations) to lead a team responsible for deviation management and CAPA workflows in Cell Therapy manufacturing.

You will assure regulatory compliance and drive RCA-based problem solving across the QA Ops function. The role requires a Bachelor's in a scientific/engineering field plus 6+ years of GxP experience, with at least 3 years in leadership and deviation/CAPA records.

Qualifications

• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree or equivalent combination acceptable.
• Minimum 6 years of progressive GxP experience in biotech/pharma manufacturing.
• Minimum 3 years of leadership experience with deviation and CAPA records.
• Solid knowledge of FDA and EMA regulations governing pharma/biotech operations.
• Proficiency in RCA tools and methodologies; experience with Quality Risk Management.

Responsibilities

• Oversee and mentor a team responsible for review, investigation, and approval of Deviations and CAPA records.
• Lead trend investigations, continuous improvement initiatives, and quality projects.
• Support hiring and development, onboarding, and a culture of accountability.
• Collaborate with cross-functional partners to ensure robust impact assessments and timely CAPA implementation.
• Maintain a strong presence within QA Operations and uphold regulatory compliance.

Skills

GxP knowledge

Root Cause Analysis

CAPA management

Quality risk management

Regulatory compliance

Education

Bachelor's degree in science or engineering

Advanced degree acceptable

Job description

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .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 ResponsibilitiesOversee 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.QualificationsBachelor'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.If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Bothell - WA - US: $133,660 - $161,968The 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 OffUS 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 holidaysBased 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: T he 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.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.Supporting People with DisabilitiesBMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.Candidate RightsBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/Data ProtectionWe will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail] . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.R1604960 : Sr. Manager - QA Ops, Investigations