Sr Director Clinical Quality Assurance (GCP)

Job Title: Senior Director, Clinical Quality Assurance 3 days onsite in South San Francisco per week Relocation Assistance provided Job Overview: The Senior 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, provide operational guidance to development teams, and lead the internal GCP QA team. Key Responsibilities: 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. Qualifications: Bachelor's or advanced degree in Biology, Chemistry, or related field, with 12 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 Requirements: Some travel required for inspections, audits, and meetings.