Senior Specialist, QA Investigations

Role: Senior Specialist, QA Investigations at Bristol Myers Squibb, responsible for quality oversight of deviation investigations and related records at the Summit Cell Therapy Facility. Responsibilities include reviewing and approving investigations, CAPAs, technical reports, and risk assessments; ensuring root cause analysis and corrective actions are effective; analyzing quality metrics; supporting inspections; and facilitating cross-functional communication. Requirements: Bachelor’s degree in STEM; 4+ years in regulated industry with deviation experience; proficiency with electronic systems and root cause analysis tools; strong analytical, technical writing, and communication skills; ability to interpret data and work in a fast-paced environment. Preferred: Experience with FDA/EMA regulations, biopharmaceutical or cell therapy manufacturing, and GxP compliance. High-value: Cell therapy focus, deviation management, root cause analysis, compliance with GMP regulations, and cross-functional collaboration. Work setup: Shift Sun-Wed, 8AM-6PM, at NJ site with potential for related responsibilities in quality oversight.