Quality Assurance Director, CGT Process

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking an Associate Director to provide end-to-end quality oversight for cell and gene therapy programs across clinical development, commercialization, and post-approval lifecycle management.

You will lead quality assurance activities, develop CGT-quality frameworks, and partner with Manufacturing, Technical Operations, Regulatory Affairs, and Quality to ensure patient safety and product quality throughout the lifecycle.

Qualifications

• Bachelor's degree in a scientific or allied field; advanced degree preferred.
• Minimum 8 years of experience in a regulated pharmaceutical environment.
• Experience with QA/QC activities in cell therapies and GxP compliance.

Responsibilities

• Provide end-to-end QA oversight for product lifecycle from development to post-approval.
• Lead QA reviews of stage-gate deliverables, tech transfers, and process validations.
• Develop and maintain quality frameworks aligning with regulatory CGT expectations.
• Partner with cross-functional teams to drive continuous improvement.
• Support inspections, health authority interactions, and regulatory submissions.

Skills

QA SME

GXP QA

Cell Therapy

Education

Bachelor's degree

Master's degree (preferred)

8+ years experience

Tools

MES

LIMS

eQMS

Data visualization

Job description

Vertex Pharmaceuticals Incorporated is seeking an Associate Director to provide end-to-end quality oversight for cell and gene therapy programs across clinical development, commercialization, and post-approval lifecycle management.

You will lead quality assurance activities, develop CGT-quality frameworks, and partner with Manufacturing, Technical Operations, Regulatory Affairs, and Quality to ensure patient safety and product quality throughout the lifecycle.