Senior Director, Head of Quality Control, T1D Mfg Ops

Role: Senior Director, Head of Quality Control, overseeing QC strategy and external laboratory partnerships for Vertex's Type 1 Diabetes Cell Therapy manufacturing network. Responsibilities: lead QC network oversight, including testing governance, method transfer, assay implementation, and performance monitoring across CDMOs and external labs; ensure compliance and reliability of release testing, microbiology, environmental monitoring, and stability assays; partner with QA, Manufacturing, and Regulatory teams to support supply continuity and regulatory readiness. Qualifications: advanced degree in Biology, Biochemistry, or related field; 15+ years in biotech or cell therapy, with 8+ years of leadership experience managing GMP QC organizations; deep expertise in QC operations for complex biologics or cell therapies, including outsourced testing and method lifecycle management. Preferred: PhD, experience scaling QC for late-stage clinical or commercial manufacturing, familiarity with LIMS and automation, and supporting regulatory submissions. HighValue: focus on advanced therapies, cell-based and molecular assays, GMP compliance, external testing oversight, and cross-functional leadership in a regulated environment. WorkSetup: hybrid or on-site; flexible regarding location.