Product Development Quality: Provides oversight of analytical development, manufacturing, testing and distribution of clinical supplies (investigational products) including drug substance and drug product batch disposition, support product certification and release activities, and audits of internal GMP systems/processes and suppliers/third party contractors. RDQ provides independent oversight, auditing, compliance, risk management, and quality expertise across nonclinical, clinical, product development, device, pharmacovigilance, and third-party/vendor oversight activities to ensure regulatory compliance, data integrity, patient safety, and inspection readiness.