Quality & Lifecycle Director, Cell & Gene Therapy

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

Benefits offered by this job

Annual bonus

Annual equity awards

Job summary

Vertex Pharmaceuticals seeks an Associate Director of Manufacturing Process & Technical Quality in Boston to oversee end-to-end quality for cell and gene therapy programs across development, commercialization, and post-approval lifecycle management.

You will lead QA reviews, drive quality frameworks, and partner with Manufacturing, Regulatory Affairs, and Quality to ensure regulatory alignment and patient safety. The role blends strategy with hands-on governance in a hybrid work setting.

Qualifications

• Bachelor's degree in a scientific or allied health field required.
• 8+ years in a regulated pharmaceutical environment.
• Experience with cell therapies or CGT advantageous.

Responsibilities

• Provide QA oversight across product lifecycle from development to post-market.
• Lead reviews of stage-gate deliverables, tech transfers, process validations, and new product introductions.
• Develop and maintain quality frameworks aligned with regulatory expectations.
• Collaborate with Manufacturing, Regulatory Affairs, and Quality to support governance.
• Support inspections readiness and Health Authority inquiries.

Skills

QA subject matter expert

Regulatory knowledge

Data analytics

Root cause analysis

Operational excellence

Cross-functional collaboration

Critical thinking

Education

Bachelor's degree in science or allied health

Master's degree (Business/Scientific)

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

Vertex Pharmaceuticals seeks an Associate Director of Manufacturing Process & Technical Quality in Boston to oversee end-to-end quality for cell and gene therapy programs across development, commercialization, and post-approval lifecycle management.

You will lead QA reviews, drive quality frameworks, and partner with Manufacturing, Regulatory Affairs, and Quality to ensure regulatory alignment and patient safety. The role blends strategy with hands-on governance in a hybrid work setting.