Develop, maintain, and execute the risk-based internal audit universe and annual audit schedule in alignment with the audit strategy and priorities established by the Director, leveraging applicable requirements, process and product risk, prior findings, CAPA effectiveness, external audit outcomes, organizational changes, performance trends, and emerging regulatory intelligence to proactively identify priorities, strengthen compliance, and support continuous organizational improvement. Lead assigned external audit and inspection readiness activities and serve as the Director’s primary technical and operational partner for FDA, notified body, MDSAP, customer, and other regulatory or certification audits, including readiness plans, mock audits, SME preparation, evidence-room strategy, request tracking, interview coaching, daily debriefs, and rapid escalation of potential risks to ensure organizational preparedness and confidence.