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Otsuka Pharmaceutical Companies (U.S.)
Manager, Global Quality Management - Clinical Audit
Otsuka Pharmaceutical Companies (U.S.) Saint Paul, MN, 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...

Dec 19, 2025
Otsuka Pharmaceutical Companies (U.S.)
Senior Manager, Global Quality Management - Clinical
Otsuka Pharmaceutical Companies (U.S.) Saint Paul, MN, USA
Job Summary The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle. Key Responsibilities Clinical Study Support Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out. Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance. Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance. Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices...

Dec 19, 2025
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