Executive Director, GMP Quality

Role: Senior GMP Quality leader overseeing quality operations at Ionis' Carlsbad campus and Faraday facility, supporting drug development through commercial manufacturing. Responsibilities: provide strategic direction on GMP processes for drug substance and product, ensure compliance with global regulations (FDA, EU, MHLW, TGA), lead audit and inspection readiness, and manage relationships with CMOs and internal teams. Requirements: minimum 20 years in GMP Quality or compliance, with 10+ years in senior leadership roles in biotech/pharma manufacturing; experience in biologics, drug substance, and complex pharmaceutical operations; strong expertise in regulatory inspections, investigations, CAPAs, and risk management; degree in scientific or engineering discipline preferred. HighValue: biologics, drug substance/product manufacturing, GMP compliance, global regulatory inspections, biologics and complex pharma operations, senior leadership, strategic quality oversight. WorkSetup: onsite in Carlsbad, CA.