Executive Director, Quality Systems & Operational Excellence Lead

Role: Lead QMS design and operational excellence for a biopharma developing therapies for MASH, including Rezdiffra (resmetirom), a Phase 3 liver disease treatment. Responsibilities: establish and harmonize QMS standards, templates, and governance; drive process simplification, cycle-time reduction, and KPI management; ensure audit readiness and inspection preparedness; lead quality event trending and lifecycle performance reviews. Requirements: BS in Life Sciences, Engineering, or Quality; 18+ years in GxP quality systems with audit support, lifecycle oversight from development to commercial, and proven governance leadership; experience with digital quality initiatives preferred. HighValue: Quality Systems leadership in biopharma, lifecycle management, GxP compliance, virtual biotech environment, experience with Veeva Vault or similar platforms, and expertise in continuous improvement and inspection readiness across drug development and commercialization stages.