Manager, Global Product Quality – 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.
• Warehousing & 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 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 &:
  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.

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 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.
• 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.
• Ability to work effectively in a global, cross-functional, and matrixed environment.

Preferred Experience

• Experience with electronic Quality Management Systems (eQMS) such as Veeva, Track Wise, or similar.
• Certification in DEA compliance, Quality Assurance, or Regulatory Affairs.

Minimum $104,640 — Maximum $156,400, plus incentive opportunity.

Posted for a minimum of 5 business days.

Comprehensive medical, dental, vision, prescription drug coverage, company basic life, accidental death & dismemberment, short-term & long-term disability, tuition reimbursement, student loan assistance, 401(k) match, flexible time off, paid holidays, paid leave.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.