Director, Corporate Quality - GCP

Role: Director, Corporate Quality overseeing clinical development and real-world evidence, ensuring compliance with GCP, GLP, and FDA regulations. Responsibilities: provide strategic quality leadership, partner with R&D teams to resolve compliance issues, develop CAPAs, review clinical documentation, support audits and inspections, and maintain GxP-compliant procedures within a robust Quality Management System. Qualifications: BS/BA in a scientific field; 12+ years of industry experience; 8+ years in Clinical Quality Assurance, with strong knowledge of global clinical trial regulations, FDA, ICH guidelines, and experience with regulatory inspections. Preferred: experience in Non-Clinical QA, development of QMS, and supporting inspections. High-Value: clinical and non-clinical GCP/GLP compliance, global trial oversight, experience supporting regulatory inspections, up to 10% travel. WorkSetup: hybrid (U.S. based), occasional domestic and international travel.