Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT

Vertex Pharmaceuticals · Boston, MA

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QualityFull-time$157k–$235kCompany career page

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Role summary

Associate Director role providing quality oversight for cell and gene therapy programs from clinical development through post-approval lifecycle management. Responsible for establishing product quality standards, ensuring regulatory compliance, and mitigating quality risks across manufacturing operations and contract partners.

What they're looking for

Bachelor's degree in scientific or allied health field
8+ years experience in regulated pharmaceutical quality assurance environments
In-depth knowledge of global regulatory requirements and GxP activities in cell therapies
Experience with quality systems platforms such as MES, LIMS, eQMS, and data analytics tools
Demonstrated expertise in root cause analysis and operational excellence methodologies
Master's degree in business or scientific field preferred

What you'll be doing

Serve as quality subject matter expert for product and process lifecycle management across development, commercialization, and post-approval stages
Lead QA review and approval of stage-gate deliverables, process validations, technology transfers, and regulatory submissions
Develop and implement quality frameworks, standards, and compliance strategies aligned with evolving regulatory expectations
Lead investigations, deviations, and change controls to identify risks and implement mitigation strategies
Provide quality oversight for internal manufacturing and external contract manufacturing organizations

Key requirements

Therapeutic area: Rare Disease

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