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. 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.

• 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.

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

• Accountability for Results – Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving – Make decisions considering the long‑term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity – Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication – Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration – Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development – Play an active role in professional development as a business imperative.

Minimum $ - Maximum $, plus incentive opportunity:
The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum.

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