Global Product Quality Manager - Controlled Substances

We are searching for a passionate Global Product Quality Manager for Controlled Substances. In this pivotal role, you will ensure that every step involving controlled substances adheres to Good Manufacturing Practices (GMP) and meets global regulatory standards, including DEA regulations. You will work closely with teams from R&D, Supply Chain, Product Development, and Warehousing & Distribution, providing quality oversight and regulatory compliance throughout the lifecycle of controlled substances.

Your expertise will play a vital role in supporting quality for both clinical and commercial products, ensuring that manufacturing, testing, packaging, storage, and distribution comply with Current Good Manufacturing Practices (CGMP), Otsuka Quality Standards, and all relevant regulations.

• Product Oversight: Deliver robust GMP oversight and expert guidance during the drug development process, including thorough documentation review and approval. Act as a primary point of contact with regulatory agencies and internal compliance teams regarding controlled substances.
• Quality & Compliance: Spearhead initiatives that ensure quality and compliance for controlled substances, aligning operations with DEA regulations and global standards. Develop, implement, and maintain SOPs for compliant handling, storage, and distribution of controlled substances.
• Audit & Inspection Readiness: Ensure thorough preparation for and support during DEA inspections, audits, and regulatory submissions, guaranteeing comprehensive documentation and readiness.
• Process Optimization: Manage quality systems related to product quality complaints, CAPA, deviations, and change control specific to controlled substances.
• Data Analysis & Reporting: Monitor compliance metrics and trends to proactively identify risks and lead continuous improvement initiatives.
• Cross-functional Collaboration: Foster collaboration with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are seamlessly integrated throughout the lifecycle of controlled substance products.
• Training & Documentation: Provide essential training and guidance on controlled substance regulations and GMP expectations to global teams; author and maintain relevant SOPs and quality documentation.

• 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 focused on pharmaceutical quality, particularly related to controlled substances.
• In-depth knowledge of DEA regulations and compliance responsibilities, especially with regard to registration and recordkeeping.
• Familiarity with FDA/ICH/USP requirements, including relevant sections of 21 CFR and ICH Q7.
• Proven ability to manage quality systems within regulated environments.
• Experience overseeing warehousing and distribution processes for controlled substances.
• Exceptional communication, collaboration, and project management skills.
• Detail-oriented with strong technical writing skills for documentation.
• Adept at thriving in a global, cross-functional, and matrixed organizational environment.

• Familiarity with electronic Quality Management Systems (eQMS).
• Certification in DEA compliance, Quality Assurance, or Regulatory Affairs.

This position offers a competitive salary range from $104,640 to $156,400, along with an incentive opportunity. In addition to the salary, Otsuka offers a comprehensive benefits package that includes medical, dental, vision, and prescription drug coverage, as well as life and disability insurance, tuition reimbursement, and a generous 401(k) match, among other valuable benefits.

If you are excited by this opportunity and meet the required qualifications, we encourage you to apply!

Global Product Quality Manager Controlled Substances
• Raleigh, NC, United States