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Duke University Health System
Durham, North Carolina
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QA Manager, Cell and Gene Therapy
The QA Manager will be accountable for the oversight of Quality Assurance Operations within CTCEF Manufacturing . This function safeguards compliance to current 21CFR/FDA regulations, FACT/ Immune Effector Cells regulations, current Good Manufacturing Practices (GMP), MSK and CTCEF Standard Operating Procedures (SOPs). The QA Manager is responsible for managing and supporting all aspects of Quality Assurance and the QA personnel within the multi-user Cell Therapy and Cell Engineering Facility (CTCEF) of MSK while also ensuring integrity of CTCEF products. You will: Supervise and manage the activities of the CTCEF Quality Assurance team while also hiring, training, and mentoring. M
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