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The Director, GCP Quality Assurance (QA) will support the organization by providing GCP QA oversight for Phase 1-3 clinical trials. In this position, the incumbent will be actively involved in executing GCP QA strategy by participating on project teams, contributing to risk-based assessments, providing GCP QA support to foster cross-functional partnerships, and implementing regulatory intelligence processes. This role will be involved in review of investigational and product licensure documents, support clinical sites on compliance issues for Phase I-III trials, surveillance of Pharmacovigilance and product complaints activities, internal and external audits of data sources to ensure integrity and accuracy of study data, and provide quality training of GCP staff. Additionally, the Director, GCP QA will lead and manage quality with external CROs, oversee execution of GCP audit plans, review reports and track corrective actions.