Director GCP Quality Assurance

Job ***** Director, Clinical Quality Assurance3 days onsite in South San Francisco per weekRelocation Assistance providedJob ** The Director of Clinical Quality Assurance (GCP) will ensure the quality of clinical programs throughout their lifecycle, including oversight, risk assessment, and compliance with regulatory standards. This role will drive the quality strategy and provide operational guidance to development teams.Key *Develop and maintain GCP QA programs, ensuring compliance with health authority regulations and guidelines.Lead audit planning and execution, provide quality oversight for clinical documents, and ensure inspection readiness.Support clinical service provider selection, manage KPIs, and guide cross-functional teams on quality matters.*Bachelors or advanced degree in Biology, Chemistry, or related field, with 10+ years of GCP/GVP QA experience.Strong knowledge of FDA, ICH, and global health authority regulations, with experience in small molecule products.Proven leadership skills, ability to make sound decisions in complex environments, and prior management experience.Additional **Some travel required for inspections, audits, and meetings.

Created: 2025-03-06