Associate Director, Clinical R&D QA US

Role: Senior Manager, Clinical R&D QA, providing GCP oversight for clinical development programs within Incyte's Hematology, Oncology, and Autoimmunity pipeline. Responsibilities: conduct and manage GCP audits of investigator sites, vendors, and trial documentation; lead regulatory inspection activities; support quality system maintenance including deviations and SOP reviews; provide GCP guidance across clinical teams; mentor junior QA staff; ensure compliance with ICH GCP and regulatory standards; oversee responses to findings and promote quality culture. Requirements: Bachelor’s in science or healthcare; 5-7 years in GCP QA or clinical compliance in pharma/biotech; minimum 5 years of GCP audit experience; regulatory inspection experience; excellent communication skills; willingness to travel up to 30%; office-based. High-Value: GCP oversight, clinical audits, investigator site/vendor inspections, regulatory inspections, global clinical programs, focus on Hematology/Oncology, GCP compliance, QA systems. WorkSetup: office-based, with up to 30% travel.