Otsuka Pharmaceutical Companies (U.S.)
Madison, WI, USA
The Manager, Manufacturing Product Quality (Small molecule) is responsible for ensuring GMP compliance in the manufacturing packaging, labeling, and distribution of commercial and clinical trial materials across global operations. This role supports the oversight of manufacturing and packaging activities performed internally and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the commercial and clinical supply chains. 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 manufacturing and packaging through delivery. Key Responsibilities Oversee manufacturing of commercial and clinical products at contract manufacturers to ensure compliance with GMP, and applicable global regulatory requirements. Performs batch record review and quality release...
