Global QC Leader for Cell Therapy & CDMO Network

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 216,000 - 324,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

Educational assistance

Commuting subsidy

401(k)

Job summary

Vertex Pharmaceuticals Incorporated seeks 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 build and scale a robust QC partnership model supporting complex stem cell-derived therapies across CDMOs, external testing laboratories, and commercial/clinical supply operations.

You will guide outsourced testing governance, method transfer, assay readiness, and

Qualifications

• Advanced degree in Biology, Cell Biology, Molecular Biology, Biochemistry, Analytical Chemistry, Bioengineering, Pharmaceutical Sciences, or related field.
• Typically 15+ years of relevant industry experience in biotechnology, biopharmaceutical, stem cell therapy, or advanced therapies.
• 8+ years of progressive people leadership experience.
• 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, qualification/validation, assay lifecycle management, and labs.
• Strong understanding of cGMP, data integrity, regulatory expectations, and inspection readiness.
• Proven ability to influence across Manufacturing, QA, Analytical Development, Regulatory, and operations.

Responsibilities

• 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.
• Ensure timely, compliant execution of critical assays for product quality and lot release across external labs.
• Lead method transfer, assay implementation, lab readiness, and performance governance for CDMOs and contract test labs.
• Oversee QC investigations, assay performance trends, data review, and testing-related escalation across the network.
• Partner with QA, Manufacturing, MSAT, Analytical Development, Supply Chain, and Regulatory teams to ensure continuity of supply and analytical readiness.

Skills

QC for cell therapy

GMP laboratory operations

CDMO oversight

Leadership

Education

Advanced degree in Biology/related field

15+ years biotech experience

8+ years leadership

Tools

LIMS

Electronic lab systems

QC automation

Job description

Vertex Pharmaceuticals Incorporated seeks 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 build and scale a robust QC partnership model supporting complex stem cell-derived therapies across CDMOs, external testing laboratories, and commercial/clinical supply operations.

You will guide outsourced testing governance, method transfer, assay readiness, and