GCP/GVP QA Director

Job description

The GCP/GVP QA Director is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP/GVP processes, supports internal/external audits, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity. Develops and implements GCP and GVP functional strategy to support cross-functional deliverables to ensure that quality is embedded within all steps of Exelixis clinical research and operations. Assists in the management of Exelixis partnerships and collaborations and forges strong relationships. Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with cGCP and understanding of the international regulatory landscape. ESSENTIAL DUTIES/RESPONSIBILITIES: As QA Partner, responsible for assisting the development of internal processes and systems related to GCP/GVP activities. Provides direct support to development and clinical study teams; participates in QA planning and implementation to support study operations, development and approval of Clinical a...