Senior Director, Head of Quality Control, T1D Mfg Ops

Vertex Pharmaceuticals seeks a Senior Director to lead quality control strategy and external laboratory oversight for Type 1 Diabetes cell therapy manufacturing. The role focuses on building and scaling a QC partnership model across contract manufacturers and testing laboratories, ensuring compliant execution of critical assays supporting product quality and lot release.

Responsibilities

• Lead QC strategy and external oversight for stem cell therapy manufacturing and testing partners across CDMOs and contract laboratories
• Oversee release, in-process, raw material, stability, microbiology, and environmental monitoring testing activities and assay performance
• Lead method transfer, assay implementation, lab readiness, and performance governance across external laboratory network
• Manage QC investigations, assay performance trends, data review expectations, and escalation management across partners
• Partner with QA, Manufacturing, Analytical Development, Supply Chain, and Regulatory teams to ensure supply continuity and analytical readiness

Requirements

• Advanced degree in Biology, Cell Biology, Molecular Biology, Biochemistry, Analytical Chemistry, Bioengineering, or Pharmaceutical Sciences
• 15+ years biotechnology or advanced therapy industry experience; 8+ years progressive people leadership managing managers and cross-functional teams
• Deep QC expertise for cell therapy, stem cell-derived, or complex biologic products in regulated environments
• Demonstrated success with method transfer, assay lifecycle management, lab investigations, and GMP laboratory operations
• Strong understanding of cGMP, data integrity, regulatory expectations, and inspection readiness
• Proven ability to influence across Manufacturing, Quality Assurance, Analytical Development, and Regulatory functions
• Experience building or scaling QC organizations; familiarity with external testing networks and CDMOs preferred

Compensation: $216,000 - $324,000 base