Lead and/or provide oversight for investigation and management of significant Clinical Study Quality Events: Identify, communicate, and escalate significant incidents of GCP non-compliance, quality risks, and inspection-readiness concerns, and drive timely resolution, ensuring appropriate executive visibility, escalation, and risk-based decision-making. Partner with CMC Quality, Clinical Operations, and senior cross-functional stakeholders to facilitate the investigation, escalation, and resolution of clinical supply quality issues such as temperature excursions, product complaints, and deviations reported from clinical sites, ensuring appropriate risk assessment, stakeholder communication, and CAPA linkage when applicable.