Associate Director, Global GCP QA

Role: Associate Director, Global GCP QA, overseeing compliance and quality assurance for clinical studies at a clinical-stage biopharma developing small molecule therapies for cardiovascular, metabolic, and pulmonary diseases. Responsibilities: provide independent QA oversight for global clinical programs, review regulatory submission documents, monitor vendor and investigator site compliance, lead audits, support inspection readiness, and drive continuous quality improvement initiatives aligned with ICH GCP, FDA, EMA, and other international standards. Requirements: BS/MS in a scientific discipline, 8+ years in pharmaceutical/biotech QA with at least 4 years as a GCP lead auditor; experience in supporting regulatory inspections (FDA, EMA, MHRA, NMPA, PMDA); expertise in global GCP regulations, GxP systems, and vendor oversight; auditor certifications/SQA RQAP preferred. HighValue: global GCP compliance, clinical trial oversight, vendor and audit management, supporting regulatory inspections, experience with ICH E6/E8, 21 CFR Part 11, EU Annex 11. WorkSetup: remote or onsite (hybrid if onsite), with up to 50% travel.