Manager of Controlled Substances Quality

Job Summary

A company is looking for a Manager, Global Product Quality - Controlled Substances.

Key Responsibilities

• Provide GMP oversight and guidance during the drug development process, including documentation review and supplier collaboration
• Ensure adherence to DEA regulations and global controlled substance requirements, developing and maintaining SOPs for compliance
• Support DEA inspections and audits while overseeing quality systems related to product quality complaints and process optimization

Required Qualifications

• Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field
• 5 - 7 years of experience in a regulated industry, with 3-5 years in pharmaceutical quality, specifically in controlled substances
• Expertise in DEA regulations and compliance, including registration and recordkeeping
• Strong understanding of GMP requirements for controlled substances
• Experience managing quality systems in a regulated environment