Senior Specialist, Quality Assurance Investigations, Cell Therapy

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 materials, manufacturing, laboratory, facility, and computer systems. Author, review, and approve technical reports, such as risk assessments and deviation system monitoring reports, to support the deviations program. Ensure corrective and preventive actions are robust and adequately address root causes. 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 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 Specific Knowledge, Skills, Abilities Research, understand, interpret and apply internal policies and regulatory guidelines. Proficient computer skills with knowledge of MS Office, Smartsheet, and ability to learn new software applications. Interpret data and results, understand problems with few variables, and critically assess proposed CAPAs. Critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with quality risk management principles. Excellent verbal and technical writing skills; prepare written communications and present technical data to management with clarity. Work effectively in a fast-paced team environment with changing priorities. Detail oriented, task focused, and able to meet deadlines and support work prioritization. Collaborate across functional groups and teams to ensure requirements are met. Self-motivated and contribute to a positive team environment. Demonstrate ability to make decisions for minor issues and recognize quality issues to solve problems. Curious and think critically to create innovative solutions. Education & Experience Bachelor’s degree in a STEM field preferred; high school diploma or associate’s degree with equivalent 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 or EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Demonstrated experience with electronic systems and databases. Demonstrated experience with root cause analysis tools such as 5‑WHY, Human error prevention, Ishikawa diagram, process flow diagram. Compensation Overview Devens, MA – The salary range is 89780 to 108789 for a full-time employee. Additional incentive cash and stock opportunities may be available. Final compensation is based on demonstrated experience. Equal Employment Opportunity Statement BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. BMS will consider qualified applicants with arrest and conviction records in accordance with applicable laws in the applicant’s area. #J-18808-Ljbffr Bristol Myers Squibb