Senior Director, QC Strategy & External Lab Partnerships

Vertex Pharmaceuticals; Boston (MA); On-site; USD 216,000 - 324,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a Senior Director, Head of Quality Control to lead QC strategy and external laboratory oversight for our cell therapy manufacturing network. The role drives method transfer, assay readiness, and performance governance across CDMOs and contract labs to ensure product quality and supply continuity.

The leader will oversee outsourced testing governance, budget, and sample management, while partnering with QA, MSAT, Regulatory, and Manufacturing to maintain high

Qualifications

• Advanced degree in Biology, Cell Biology, or related field.
• Typically 15+ years of industry experience in biotechnology/biopharmaceuticals.
• 8+ years of progressive people leadership experience.
• Demonstrated success leading GMP Quality Control in a regulated environment.
• Deep knowledge of QC operations for complex biologic or cell therapy products.
• Strong experience with method transfer, qualification/validation, and assay lifecycle management.
• Strong understanding of cGMP and data integrity.

Responsibilities

• Lead QC strategy and external QC oversight for stem cell therapy partners.
• Oversee outsourced release, in-process, raw materials, stability, microbiology, and environmental monitoring testing.
• Ensure timely, compliant, and reliable execution of critical assays across external laboratories.
• Lead method transfer, assay implementation, lab readiness, and governance for CDMOs and contract labs.
• Oversee QC investigations, assay performance trends, data review, and testing escalations across the network.
• Partner with QA, Manufacturing, MSAT, Analytical Development, Regulatory to ensure continuity of supply and analytical readiness.

Skills

QC strategy

GMP operations

Cross-functional leadership

Regulatory readiness

Data integrity

CDMO oversight

Education

PhD in a relevant field

Tools

LIMS

Electronic lab systems

QC automation tools

Job description

Vertex Pharmaceuticals is seeking a Senior Director, Head of Quality Control to lead QC strategy and external laboratory oversight for our cell therapy manufacturing network. The role drives method transfer, assay readiness, and performance governance across CDMOs and contract labs to ensure product quality and supply continuity.

The leader will oversee outsourced testing governance, budget, and sample management, while partnering with QA, MSAT, Regulatory, and Manufacturing to maintain high