The worker will collaborate with Quality R&D Third Party, R&D project teams, technical and supply functions, regulatory and clinical supply partners, procurement or third-party management functions, and external manufacturing or service providers, as applicable to the assigned work package. Review and assess third-party quality management system records, including deviations, complaints, change controls, corrective and preventive actions (CAPAs), investigations, and validation-related documentation, and ensure timely follow-up in accordance with cGMP and quality agreements.