Director, GLP Quality Assurance

Role: Director of GLP Quality Assurance at a late-stage oncology biopharma developing RAS-targeted therapies, responsible for ensuring GLP compliance across internal and external research labs supporting clinical studies. Responsibilities: develop audit plans, perform/vendor audits, review study protocols and reports for compliance, monitor vendor QA activities, manage regulatory adherence (e.g., 21 CFR Part 58, OECD, ICH GCP), and provide GLP training and SOP development. Requirements: Bachelor’s or Master’s degree with 12+ years of global GLP QA experience, extensive audit management skills. Preferred: RQAP-GLP certification, strong regulatory knowledge, experience with bioanalytical, PK, biomarker labs, and computerized systems validation. HighValue: experience with testing facilities, bioanalytical labs, biorepositories, and AI/ML in biomarker labs; knowledge of US and EU GLP/GCP regulations. Collaboration: liaises with vendors, internal nonclinical and clinical teams, and QA management. WorkSetup: onsite in Redwood City, CA, with salary range $211K-$264K, competitive benefits, and development opportunities.