Senior Director, Head of Quality Control, T1D Mfg Ops
Vertex Pharmaceuticals · Boston, MA
QualityFull-time$216k–$324kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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