Otsuka Pharmaceutical Companies (U.S.)
Boston, MA, USA
The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. Key Responsibilities Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers. Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. Quality & Compliance:Serve as the quality and compliance lead for controlled...
