Director, Manufacturing Process & Technical Quality - CGT
Listed on 2026-10-06
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Director of Manufacturing Process & Technical Quality
overseeing quality assurance and compliance for Cell & Genetic Therapies from development to post-approval. Responsibilities include translating quality strategy into operational plans, ensuring adherence to GxP and regulatory standards, leading product lifecycle quality activities, supporting manufacturing readiness, and managing risk and compliance. The role involves cross-functional collaboration with Development, Manufacturing, Regulatory, and external partners, and supports regulatory inspections and submissions.
Qualifications:
Bachelor's in life sciences, biotech, or engineering; 10+ years in biotech/pharma quality, manufacturing, or technical operations; at least 3 years of leadership experience; deep knowledge of global GXP regulations, cell and gene therapy technologies (e.g., AAV, aseptic processing); experience across clinical to commercial stages; strong leadership, communication, and influence skills.
High-value specifics include focus on Cell & Gene Therapy, biologics, regulatory submission support, and lifecycle quality oversight.
Work setup is hybrid or on-site with up to 25% travel.
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