Otsuka Pharmaceutical Companies (U.S.)
Indianapolis, IN, USA
The Manager, Global Product Quality - Clinical Packaging is responsible for ensuring GMP and GCP compliance in the packaging, labeling, and distribution of clinical trial materials across global operations. This role supports the oversight of clinical packaging activities performed internally and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the clinical supply chain. The manager will collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Supply Chain to ensure the integrity and traceability of investigational products from packaging through delivery. Key Responsibilities Oversee clinical packaging operations to ensure compliance with GMP, GCP, and applicable global regulatory requirements. In collaboration with the supplier quality team, support qualification and monitoring of external clinical packaging vendors, including audits and performance...


