Director, Head of Compliance

Role: Director of Quality Compliance at Bristol Myers Squibb's Summit West Cell Therapy (CAR T) manufacturing site, responsible for developing and maintaining site compliance programs to ensure high quality standards. Responsibilities: lead internal audits, manage health authority inspections (FDA, EMA, Health Canada, PMDA), maintain risk registers, identify compliance trends, conduct gap assessments, lead investigations, communicate quality events to leadership, author compliance reports, and ensure inspection readiness. Requirements: BS in Science or Engineering, 12+ years management experience in regulated industries, comprehensive knowledge of QA, QC, validation, and regulatory processes; proven experience with global inspections and building high-performing teams. Preferred: MS in relevant field, experience in CAR T, biologics, or pharma, expertise in continuous improvement or Six Sigma. High-Value: biologics, cell therapy, CAR T, post-approval manufacturing, GxP compliance, regulatory inspection management, quality risk and data integrity programs. Location: Summit, NJ, on-site with leadership oversight; role emphasizes cross-functional collaboration with senior stakeholders and regulators.