Senior Director Cell & Genetic Therapies Quality - Personalized Medicine

Role: Senior Director, CGT Quality Systems, Personalized Medicine, provides strategic leadership for quality oversight of cell and gene therapies throughout development and commercial stages. Responsibilities: oversee global quality systems, ensure compliance with GxP and regulatory standards, lead risk management, and drive continuous improvement; manage quality governance for personalized medicine and advanced CGT programs; collaborate cross-functionally with Manufacturing, Regulatory, and Supply Chain teams; lead inspection readiness and audit activities. Requirements: Bachelor's or Master's in life sciences, engineering, or related field; 15+ years in regulated pharma/biotech, with 7+ years in leadership roles; deep expertise in quality oversight for cell, gene, biologics, or advanced therapies, including development through commercialization; strong influence and communication skills with executive presence; knowledge of global health authority expectations and GxP. HighValue: personalized medicine, cell/gene therapy, biologics, advanced therapies; lifecycle stages from clinical to commercial; regulatory compliance, risk management, digital quality solutions; 15% travel; hybrid or on-site work options.