Vice President, Quality

Role: Vice President, Quality leading LeonaBio’s quality function during late-stage clinical development, regulatory submission, and commercialization of small-molecule therapeutics for unmet medical needs, including metastatic breast cancer and ALS. Responsibilities: develop and implement scalable, phase-appropriate Quality Management System (QMS) and Quality Risk Management (QRM) frameworks; oversee GxP compliance (GMP, GCP, GVP); ensure inspection readiness; manage quality governance for external vendors including CMOs, CROs, and labs; lead quality activities across drug substance, drug product, technology transfer, validation, stability, and post-approval lifecycle; build and develop a high-performing Quality team. Requirements: Bachelor’s in a scientific discipline; 15+ years of progressive Quality experience in biotech/pharma, with leadership in late-stage clinical and commercial small-molecule product development; deep knowledge of FDA, EMA, ICH, GMP, GCP, GVP regulations; proven success in designing/transforming quality systems and managing regulatory inspections; experience overseeing outsourced manufacturing/clinical activities. Preferred: advanced degree (MS, PhD, PharmD). HighValue: small-molecule therapeutics, late-stage clinical and regulatory phases, global GxP compliance, inspection readiness, outsourcing/vendor oversight, senior leadership collaboration. WorkSetup: not specified; occasional domestic/international travel likely.