Global Manager of Product Quality - Controlled ...

Job Summary We are seeking a dedicated Global Manager of Product Quality for Controlled Substances who will play a crucial role in ensuring that all processes and activities surrounding controlled substances adhere to Good Manufacturing Practices (GMP) and comply with regulatory standards globally, including DEA regulations. This position works in collaboration with various teams including R&D, Supply Chain, Product Development, and Warehousing & Distribution, ensuring thorough quality oversight and regulatory compliance throughout the lifecycle of controlled substances. Your expertise will support quality oversight for both clinical and commercial products, guaranteeing their manufacturing, testing, packaging, storage, and distribution align with Current Good Manufacturing Practices (CGMP), Otsuka Quality Standards, and global regulatory requirements. Key Responsibilities Product Oversight: Provide GMP oversight and guidance throughout the drug development process including documentation review and approval, while ensuring effective collaboration and oversight of suppliers and contract manufacturers. Act as a key liaison with regulatory agencies and internal compliance teams on controlled substance matters. Quality & Compliance: Lead quality and compliance initiatives for controlled substances, ensuring strict adherence to DEA regulations and other global standards. Develop, implement, and maintain global SOPs for compliant handling, storage, and distribution of controlled substances, while ensuring operations meet all regulatory and internal quality standards. Audit & Inspection Readiness: Prepare for and support DEA inspections, audits, and regulatory submissions, ensuring robust documentation and readiness. Process Optimization: Oversee quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. Data Analysis & Reporting: Monitor compliance metrics and trends, identifying risks to 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 on controlled substance regulations and GMP expectations to global teams; author and maintain SOPs and related quality documentation. Qualifications Required: Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. 5-7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, especially regarding controlled substances. Strong knowledge of DEA regulations and compliance responsibilities, particularly in registration and recordkeeping. Understanding of FDA/ICH/USP requirements, including relevant sections of 21 CFR and ICH Q7. Proficient in managing quality systems in regulated environments. Experience with warehousing and distribution processes for controlled substances. Excellent skills in communication, collaboration, and project management. Detail-oriented with strong writing skills for technical documentation. Able to excel in a global, cross-functional, and matrixed environment. Preferred Experience: Experience with electronic Quality Management Systems (eQMS). Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. Company Information: This position is offered with a competitive salary range from $104,640 to $156,400, complemented by an incentive opportunity. In addition to the salary, Otsuka provides a comprehensive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, tuition reimbursement, and a generous 401(k) match, among other valuable benefits. If you meet the qualifications and are excited about this opportunity, we encourage you to apply!

Created: 2026-03-10