• Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program to ensure compliance with Good Clinical Practice(GCP)/Good Pharmacovigilance Practice(GPvP)/Good Clinical Laboratory Practice (GpLP). • Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and systems, clinical trials, investigator sites, and vendors/contract service providers (CSPs). • Plan, lead, conduct, document, report, and follow-up on clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements. • Ensure appropriate escalation to responsible management for critical audit findings and support. • Provide education and guidance on audit processes and activities. • Manage audit reports, findings, and CAPAs in Veeva Quality Management System (QMS) and review and approve finding responses and actions in system. • Develop and monitor audit finding response and CAPA timeliness performance metrics and present trends and improvement plans to senior management. • Partner with departments across organizations to ensure consistent implementation and execution of audit program. • Work independently with respect to decision making and problem solving.