artivabio
4 live roles
Job Summary: The Executive Director, GMP Quality Assurance leads Artiva Biotherapeutics’ internal GMP quality operations and compliance program, ensuring that cell therapy products manufactured and tested for clinical use meet all applicable FDA, EMA, and other global health authority requirements. This role owns the quality systems governing internal GMP manufacturing, batch disposition, deviations, CAPA, change control, and inspection readiness, and partners closely with Technical Operations (GMP and Technical Development) and Regulatory Affairs. The Executive Director builds and leads the GMP QA operations organization, sets quality policy and standards, and drives a culture of quality and continuous improvement across the company. This position operates with a high degree of independence, exercising broad judgment in interpreting regulations and resolving complex compliance issues, and reports to the VP of Quality. Duties/Responsibilities: The duties below are performed on an ongoing basis. Lead GMP Quality Assurance operations, including document control, training, and material release - ensuring consistent, compliant, and timely execution across the quality system.
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