Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA

Role: Senior Specialist, QA Investigations at Bristol Myers Squibb, focusing on quality oversight of deviation investigations and CAPAs at the Devens Cell Therapy Facility. Responsibilities include reviewing and approving investigations related to manufacturing, laboratory, and facility operations, authoring technical reports, ensuring effective corrective actions, and supporting inspections. The role also involves trending analysis, process improvement, and cross-functional communication. Requirements: Bachelor's in a STEM field (or equivalent experience), 4+ years in regulated biopharma or cell therapy industries, with at least 1 year in deviation management, and familiarity with FDA/EMA regulations. Skills: strong data analysis, investigation review, technical writing, and understanding of root cause analysis tools. Preferred: experience with electronic systems/databases, and knowledge in cell therapy manufacturing processes. The position involves compliance with GxP standards and is based at the Devens site, with onsite work and possible local travel. Candidate must demonstrate critical thinking, attention to detail, and the ability to work in a fast-paced, collaborative environment, supporting quality assurance efforts in a cutting-edge cell therapy context.