Senior Manager Quality Systems, Performance and Systems, Cell Therapy

Role: Senior Manager Quality Systems at Bristol Myers Squibb overseeing governance, strategy, and control programs to enhance quality performance at the Devens Cell Therapy Manufacturing site. Responsibilities include leading site Management Review (Quality Council), driving site performance metrics, ensuring compliance with regulatory standards, and advancing continuous improvement initiatives with a focus on automation. The role also involves leading site Quality Governance Maturity programs, coordinating APQR for commercial products, managing Quality Improvement Projects, and supporting external inspections and internal audits. Qualifications: Bachelor's in life sciences with preferred advanced degree; 8+ years of GMP/FDA-regulated biotech, cell therapy, or pharmaceutical experience, especially in Quality Risk Management, Data Integrity, Deviations, CAPA, and Management Review systems. Requires knowledge of cGMPs, regulatory standards (ICHQ10, ICHQ9), and experience with regulatory audits. Skills include strategic influence, operational excellence, and cross-functional collaboration. High-Value: Cell therapy manufacturing, quality governance, GMP compliance, regulatory inspections, operational excellence, continuous improvement, automation. Work setup: On-site at Devens, MA, with comprehensive benefits; no travel specified.