Sr. Manager - QA Ops, Investigations
About the role
Challenging. 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.
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.
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.
Pay
The starting compensation range for this full-time role in Bothell, WA is $133,660 - $161,968. 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.
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 (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 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 Year’s 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.
Schedule
BMS has an occupancy structure that determines where an employee is required to conduct their work. This role is site-by-design, which may be eligible for a hybrid work model with at least 50% onsite at the assigned facility. Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.