Director, Quality Assurance Operations

Role: Director of Quality Operations overseeing Zevra’s Quality Management System (QMS) and compliance across preclinical to commercial stages. Responsibilities include reviewing manufacturing documentation, ensuring serialization system compliance, managing investigations, CAPAs, product complaints, conducting audits, supporting regulatory inspections, and facilitating continuous quality improvement. Qualifications: 10+ years in pharma/biotech with proven leadership in quality systems, vendor oversight, and GxP compliance; 7+ years managing external relationships; experience in GCP, GLP, GDP, and product launch; Bachelor’s or higher in a scientific field. HighValue: expertise in quality assurance, vendor management, serialization, regulatory inspections, and virtual manufacturing; experience supporting early to late-stage development; international travel (~10-15%). WorkSetup: remote with domestic/international travel.