Senior GCP/PV/GLP QA Manager

Job description

SUMMARY/JOB PURPOSE (Basic purpose of the job): The Senior GCP/GVP QA Manager is accountable for assisting with the development, implementation and maintenance of end-to-end QA systems and activities for GCP/GLP operations, including planning and supporting vendor audits, and associated documentation activities. As QA Core, supports QA Partner. Ensures rapid escalation and issue resolution. 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 GCP and understanding of the international regulatory landscape. ESSENTIAL DUTIES/RESPONSIBILITIES: As QA Core, support QA Partner: Responsible for assisting the development of internal processes and systems related to GCP/GVP QA 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 audit schedule including contracting GCP/GVP audits to contractors, conducting audits, and regulatory inspections. Responsible for developing, tracking and managing periodic manag...