Hiring: Associate Director, Clinical Quality Assurance Company: Revolution Medicines Location: San Francisco Bay Area Job Posted Time: 2026-09-11 11:48:19 Employment Type: Full-time Target Skills & Keywords : GCP, Microsoft Excel, Microsoft PowerPoint, Quality Assurance, Risk Management, Root Cause Analysis, Visio About the job Experience: •10+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry. •8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities. Required Skills: •Actively facilitate and support development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines. •Partner cross-functionally with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support. •Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue. •Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management. •Partner cross-functionally with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits. •Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments. •Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation). •Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management. Qualifications: •Bachelor’s degree in scientific or technical discipline. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!