Manager, Global Product Quality

Job Summary The Manager, Global Product Quality 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. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. 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. Quality & Compliance: Serve as the quality and compliance lead for controlled substances, ensuring adherence to regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. Audit & Inspection Readiness: Support inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. Process Optimization