• Provide comprehensive technical support and expertise in risk-based quality management of clinical trials • Oversee internal and external compliance with ICH E6 R(3), Sabin organizational procedures, and applicable regulatory standards • Partner with Clinical Operations, CROs, and clinical sites to provide GXP CQA oversight • Plan and conduct audits of CROs, clinical sites, and documentation, ensuring compliance with Sabin policies and applicable regulations • Author audit reports and oversee findings until resolution, including implementation of any CAPAs through effectiveness checks • Participate in internal and external audits/ inspections including other quality assurance assigned activities