Associate Director, Clinical Quality Assurance

Role: Associate Director, Clinical Quality Assurance, responsible for leading GCP compliance and quality oversight of Revolution Medicines' clinical trials in oncology, focusing on RAS-targeted therapies. Responsibilities: develop and maintain Quality Systems; collaborate with Clinical Operations and Development teams for GCP compliance; participate in clinical study teams; review trial documents for regulatory adherence; support audit and inspection activities; manage risk assessments, CAPAs, and quality issues; ensure inspection readiness; foster cross-functional relationships. Requirements: Bachelor’s in a scientific/technical discipline; 10+ years in GCP Quality within pharma/biotech; 8+ years in audit management, inspection readiness, deviation/CAPA processes; deep knowledge of ICH GCP, FDA regulations, and drug development standards; strong communication, problem-solving, and stakeholder management skills; proficiency in Microsoft Office. Preferred: familiarity with Computer System Validation. High-Value: focus on clinical trial GCP compliance in late-stage oncology, with emphasis on RAS inhibitors, within a global regulatory environment, supporting complex clinical trials and audits. Work Setup: onsite at Redwood City, CA; salary range $186K-$233K, with comprehensive total rewards.