Senior Specialist, Quality Assurance Investigations, Cell Therapy

Position: Senior Specialist, Quality Assurance Investigations, Cell Therapy Location: Devens, MA Position Summary The Senior Specialist, Quality Assurance Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines. Key Responsibilities Review and approve investigations, CAPAs, and effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems. Author, review, and approve technical reports, including risk assessments and deviation system monitoring reports, to support the deviations program. Ensure corrective/preventive actions are robust and adequately address the root cause. Perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions. Identify improvement opportunities and support execution of site/team continuous improvement goals and projects. Support internal and external inspections as required. Maintain compliance with the assigned learning plan and support development and delivery of training content to cross‑functional teams. Lead meetings and represent the function at cross‑functional meetings. Share data and knowledge within and across teams. Build and maintain strong relationships with partner functions. Qualifications & Experience Ability to research, understand, interpret and apply internal policies and regulatory guidelines. Proficient computer skills with knowledge of MS Office, Smartsheet, etc., and ability to learn and work with new software applications. Ability to interpret data and results, understand problems with few variables, and critically assess and provide feedback on proposed CAPA. Ability to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principles. Excellent verbal and technical writing skills; ability to prepare written communications and present technical data to management with clarity and accuracy. Ability to work in a fast‑paced team environment with changing priorities. Detail oriented and task focused, with ability to meet deadlines and support work prioritization. Ability to work across functional groups and teams to ensure requirements are met. Self‑motivated and contributes to a positive team environment. Confident in making decisions for minor issues and able to recognize Quality issues and solve problems. Curious and able to think critically to create innovative solutions. Education / Experience / Licenses / Certifications Bachelor's degree in a STEM field preferred. High school diploma or associate's degree with equivalent combination of education and work experience may be considered. Four or more years of experience in a regulated industry with at least one year of deviation experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred. Demonstrated experience with electronic systems and databases. Demonstrated experience in root cause analysis tools including 5‑WHY, human error prevention, Ishikawa diagram (Fishbone), process flow diagram, etc. Compensation Overview Devens, MA – $89,780 – $108,789 annually. Additional incentive cash and stock opportunities may be available. Final compensation is determined based on demonstrated experience. Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being 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: For exempt employees – unlimited paid time off with manager approval and 11 paid national holidays; additional details in local policy. Additional benefits may include unlimited paid sick time, paid volunteer days, summer hours flexibility, leaves of absence for various needs, and Global Shutdown. #J-18808-Ljbffr Bristol Myers Squibb