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

Vertex Pharmaceuticals
August 28, 2026
Full-time
Remote friendly (Boston, MA)
Worldwide
Operations
Role: Associate Director of Manufacturing Process & Technical Quality overseeing cell and gene therapy programs' quality throughout development, commercialization, and post-approval. Responsibilities: serve as QA SME for product/process lifecycle, lead review and approval of validation activities, develop and maintain compliance frameworks, support investigations, change controls, and regulatory responses, oversee internal and external manufacturing quality, and leverage digital tools and AI for quality assurance. Requirements: Bachelor's in a scientific or health field; 8+ years in regulated pharma/biotech, with experience in GxP QA/QC activities specific to cell therapies; knowledge of platforms like MES, LIMS, eQMS preferred; strong project leadership, analytical, and cross-functional collaboration skills. High-Value: cell and gene therapy (personalized medicines), late-stage clinical to post-market, GxP compliance, process lifecycle management, digital quality tools, CMC/GMP oversight. Work setup: hybrid or on-site; flexible working arrangements.