Senior Specialist, QA Investigations

Role: Senior Specialist, QA Investigations at Bristol Myers Squibb, overseeing quality assurance of deviation investigations and related records at the cell therapy manufacturing site. Responsibilities include reviewing and approving investigations, CAPAs, risk assessments, and technical reports; ensuring root cause analysis is robust; supporting inspection readiness; and facilitating continuous improvement. Qualifications: Bachelor's in STEM preferred, with 4+ years in regulated biopharma, including deviation experience; proficiency with electronic systems and root cause tools; strong analytical, communication, and teamwork skills. High-Value: Cell therapy manufacturing, quality investigations, deviation management, regulatory compliance (FDA/EMA), GxP adherence, and cross-functional collaboration. Work setup: On-site in Summit, NJ, with a Monday-Wednesday, 8AM-6PM shift; travel requirements unspecified.