Manager, Shop Floor Quality Assurance, Cell Therapy

Role: Manager of Shop Floor Quality Assurance for Cell Therapy at Bristol Myers Squibb, leading a team of 4-8 specialists on a 6am-6pm rotating shift. Responsibilities: oversee real-time quality oversight across manufacturing, QC labs, and supply chain, ensuring compliance with cGMP standards; manage deviations, batch records, and operational issues; provide guidance on quality and regulatory systems; develop standard work; foster a safety-focused, collaborative culture; and mentor staff. Qualifications: 6+ years of cGMP experience in biopharma, preferably in sterile/aseptic environments; strong knowledge of quality management systems (e.g., deviation, CAPA, batch record); experience with microbial controls, bioprocessing, and FDA/EMA regulations; proficiency with digital tools such as MES, SAP, TrackWise; BS in STEM preferred, high school diploma with equivalent experience acceptable. High-Value: cell therapy (likely autologous or allogeneic), process oversight in GMP manufacturing, quality systems, microbial control, regulatory compliance, and real-time manufacturing support. Collaboration with manufacturing, QA, and regulatory teams; onsite in Devens, MA.