Manager, Global Product Quality - Controlled Substances

Manager, Global Product Quality - Controlled Substances at Otsuka America Pharmaceutical Inc. in Boise, Idaho, United States Job Description 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 substances, ensuring adherence to DEA 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 of controlled substances. 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 DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. + Process Optimization:Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting:Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration:Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation:Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Qualifications Required + Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in in pharmaceu To view full details and how to apply, please login or create a Job Seeker account

Created: 2025-12-18