Manager, Global Product Quality - Controlled Substances

Otsuka Pharmaceutical Companies (U.S.) is seeking a Manager for Global Product Quality focused on Controlled Substances. This role is responsible for ensuring compliance with Good Manufacturing Practices and global regulatory requirements throughout the product lifecycle, particularly in relation to controlled substances.

Responsibilities:

• Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers
• 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
• Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required
• Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances
• Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives
• Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products
• Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities

Requirements:

• 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 pharmaceutical quality, with specific experience in controlled substances and commercial quality operations
• Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting
• Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7
• Strong understanding of GMP requirements and global regulatory expectations for controlled substances
• Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment
• Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances
• Excellent communication, collaboration, and project management skills
• Must be detail oriented and able to write and/or review Technical Documents
• Ability to work effectively in a global, cross-functional, and matrixed environment
• Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar
• Certification in DEA compliance, Quality Assurance, or Regulatory Affairs