Manager, Global Product Quality - Controlled Substances

Otsuka Pharmaceutical Co., Ltd.

8d

About The Position

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.

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 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

Nice To Haves

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

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.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees