Manager of Controlled Substances Quality

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