Otsuka Pharmaceutical Companies (U.S.)
Denver, CO, USA
The Global Quality Audit Manager is responsible for planning, executing, and reporting on global audits to ensure Good Clinical Practice (GCP) compliance across Contract Research Organizations (CROs), clinical laboratories, and clinical investigator sites. This role plays a critical part in maintaining the integrity of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders to identify risks, drive continuous improvement, and support inspection readiness across the clinical research landscape. Key Responsibilities Audit Execution : Plan, conduct, and report GCP audits of CROs, clinical laboratories, and investigator sites globally, ensuring compliance with ICH-GCP, local regulations, and company policies. Provide oversight to contract and consultant resources in audit...


