• Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on global level. • Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process. • Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents. • Drive and support comprehensive root cause investigations and the development of corrective and preventive actions plans and lessons learned related to escalated GxP and Quality incidents. • Ensure that the activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry; prepare for and support inspections and audits. • Develop and deliver training on incident management procedures and promote a culture of quality and accountability across the organization. • Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.