Working under the direction of the Head of Quality Assurance, the Manager partners with Clinical Operations, CMC, Regulatory Affairs, Pharmacovigilance, Nonclinical, and other functional teams to identify compliance risks, assess inspection readiness, manage audit observations and corrective actions, and ensure the organization and its critical service providers remain prepared for regulatory inspection. The role provides hands-on leadership for internal, external, vendor, and study-related audits and establishes a sustainable inspection-readiness program as the organization progresses through Phase 3 clinical development toward regulatory submission, pre-approval inspection, and commercialization readiness.