Senior Director, Head of Quality Control, T1D Mfg Ops

Job Description

Vertex is seeking a Senior Director, Head of Quality Control to lead QC strategy and external laboratory oversight for our Type 1 Diabetes Cell Therapy external manufacturing network.

This leader will be responsible for building and scaling a robust QC partnership model supporting complex stem cell-derived therapies across CDMOs, external testing laboratories, and commercial/clinical supply operations.

This role is focused on QC network oversight, including outsourced testing governance, method transfer into external laboratories, QC scheduling and budgets, sample management strategy, assay readiness, analytical performance monitoring, and QC compliance across the external network.

• Lead Quality Control strategy and external QC oversight for stem cell therapy manufacturing and testing partners
• Oversee outsourced release, in-process, raw material, stability, microbiology, and environmental monitoring-related testing activities, as applicable
• Ensure timely, compliant, and reliable execution of critical assays supporting product quality and lot release across external laboratories
• Lead method transfer, assay implementation, lab readiness, and performance governance for CDMOs and contract test labs
• Oversee QC investigations, assay performance trends, data review expectations, and testing-related escalation management across the network
• Partner closely with QA, Manufacturing, MSAT, Analytical Development, Supply Chain, and Regulatory teams to ensure continuity of supply and analytical readiness

• Deep experience in QC for cell therapy or other advanced therapy products, including outsourced testing or CDMO oversight
• Strong knowledge of GMP laboratory operations, method transfer, assay lifecycle management, and lab investigations in an external network model
• Experience overseeing cell-based, molecular, microbiological, and/or potency-related methods across internal and external labs
• Strong people leadership and cross-functional collaboration skills
• Advanced degree in a relevant scientific discipline; significant industry leadership experience required

• Advanced degree in Biology, Cell Biology, Molecular Biology, Biochemistry, Analytical Chemistry, Bioengineering, Pharmaceutical Sciences, or a related field.
• Typically 15+ years of relevant industry experience in biotechnology, biopharmaceutical, stem cell therapy, cell therapy, or other advanced therapy environments.
• 8+ years of progressive people leadership experience, including leadership of managers and cross-functional teams.
• Demonstrated success leading GMP Quality Control organizations in a regulated environment.
• Deep knowledge of QC operations supporting complex biologic, cell therapy, or stem cell-derived products.
• Strong experience with method transfer, method qualification/validation, assay lifecycle management, and laboratory investigations.
• Strong understanding of cGMP, data integrity, regulatory expectations, and inspection readiness for QC laboratories.
• Proven ability to influence across Manufacturing, Quality Assurance, Analytical Development, Regulatory, and technical operations functions.

• PhD in a relevant scientific discipline.
• Experience building or scaling QC organizations for late-stage clinical or commercial manufacturing.
• Experience with phase-appropriate assay qualification and validation strategies for advanced therapy products.
• Experience with external testing laboratories, CDMOs, or distributed manufacturing/testing networks.
• Familiarity with LIMS, electronic laboratory systems, digital data review tools, and QC laboratory automation.
• Experience supporting regulatory submissions, responses to health authority questions, and inspection…