Sr Specialist, QA Investigations

Role: Senior Specialist, QA Investigations at Bristol Myers Squibb, overseeing quality investigations related to cell therapy manufacturing. Responsibilities include reviewing and approving deviation investigations, CAPAs, technical reports, and effectiveness checks across manufacturing, laboratory, materials, and systems; ensuring robust root cause analysis and corrective actions; analyzing metrics for timely closure of quality events; supporting internal/external inspections; delivering training; and fostering cross-functional collaboration. Qualifications: Bachelor's in STEM or equivalent experience; 4+ years in regulated biopharma industry with at least 1 year in deviation management; proficiency with digital tools and root cause analysis methodologies; strong technical writing and data interpretation skills; ability to work in fast-paced, team environments with attention to detail. HighValue: experience in cell therapy (likely CAR-T or similar modalities), manufacturing oversight, regulatory compliance (FDA/EMA), GxP environments, investigations of deviations in biopharmaceuticals or cell therapy, and internal/external audit support. WorkSetup: onsite, day shift in Summit, NJ; no travel specified.