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

Role: Associate Director of Manufacturing Process & Technical Quality, overseeing quality assurance for cell and gene therapies throughout development, commercialization, and post-approval. Responsibilities: serve as QA SME for lifecycle management, review and approve process development, technology transfers, validations, and regulatory submissions; lead investigations, deviations, change controls, and compliance issues; support CMO management and external manufacturing partners; leverage digital tools, data analytics, and AI to enhance quality oversight and process monitoring; ensure compliance with GxP and Vertex QMS; support inspection readiness and regulatory interactions. Requirements: Bachelor's in scientific or health field; 8+ years in regulated pharma/biotech with GxP QA/QC experience; knowledge of cell therapy regulation and quality systems; experience with platforms like MES, LIMS, eQMS preferred; strong leadership, risk assessment, and continuous improvement skills. High-Value: cell and gene therapy, process lifecycle management, GxP compliance, digital/AI in manufacturing, regulatory engagement. WorkSetup: hybrid or on-site; flexible working options.