Senior Manager, Clinical Quality Assurance

Role: Senior Manager, Clinical Quality Assurance, responsible for ensuring clinical trial compliance and quality across all development phases. Responsibilities: lead global investigations, manage CAPA processes, oversee audits of sites and CROs, support inspection readiness, review investigation and CAPA plans, and promote a culture of quality excellence. Requirements: BA/BS, 9+ years in clinical/Pharmaceutical QA, knowledge of GCP regulations, FDA guidelines, and QMS (Veeva preferred). Certifications such as GCP QA (RQAP-GCP) are preferred. HighValue: experience across all clinical development phases, expertise in GCP compliance, familiarity with regulatory agency interactions, and proficiency with QA tools. WorkSetup: hybrid (minimum 3 days onsite) or remote in San Carlos, CA, with up to 15% travel.