Experienced R&D Professional with over 35 years in the biopharmaceutical and biotech industries, covering the full lifecycle of development across pharmaceuticals, biologics, devices, combination products, and gene/stem cell therapies. Expertise spans clinical operations, quality assurance, compliance, and clinical affairs, with roles ranging from hands-on clinical roles (CRA, Phase I unit QA/Compliance oversight) to executive leadership positions managing domestic and international teams, Study Phases I-III. Transitioned to Clinical Quality and Compliance in 2013, specializing in ICH/GCP/GLP, GPV, international regulations, audit readiness, risk management, and QMS development. Recognized as a Subject Matter Expert in audit and inspection readiness, signal detection, CAPA management, and Quality Issue resolution