Executive Director & Site Quality Lead

Role: Executive Director & Site Quality Lead responsible for building and overseeing QA and QC operations at Denali's Utah manufacturing site, ensuring GMP compliance and inspection readiness for commercial product launch. Responsibilities: lead quality control testing, batch release, environmental monitoring, and external labs; develop and maintain site quality systems; ensure compliance with GMP/GLP regulations; support GMP qualification activities; establish quality metrics and KPIs; foster site culture aligned with core values; represent quality on site and corporate leadership teams; build and develop QA/QC teams through hiring, training, and performance management. Requirements: BS in a scientific discipline; 15+ years GMP experience in pharma, including 12+ years of leadership; experience with in-house manufacturing, QC, and CMC; knowledge of 21 CFR parts, EU cGMP/GLPs, ICH guidelines; experience with inspection management and health authority interactions; familiarity with eQMS systems; ability to travel domestically and internationally. Preferred: MS and professional certifications in quality/regulatory, large molecule or commercialization experience. High-value: GMP/GLP operations, inspection readiness, large molecule expertise, site leadership, quality systems, manufacturing/CMC context.