Controlled Substance Compliance Manager - DEA

System One • Edison, NJ

409d • $120,000 - $120,000

About The Position

The Controlled Substances Compliance Manager is responsible for overseeing compliance with DEA regulations related to the handling of controlled substances within a highly regulated environment. This role involves managing inventory, training staff, coordinating destruction of substances, and ensuring adherence to regulatory standards while supporting various compliance initiatives.

Requirements

• Previous experience in supply chain management within regulated industries, especially handling controlled substances in pharmaceutical manufacturing, distribution, or healthcare.
• Deep understanding of DEA regulations, including SOM programs, drug quota management, and documentation requirements.
• Familiarity with DEA cyclic inspections and audit management processes.
• Strong ability to manage and lead teams, prioritize tasks, and maintain structured organizational processes.
• Experience in Good Documentation Practices (GDP) and maintaining accurate records for controlled substances.
• Proficient in Microsoft Office and familiar with ARCOS, SOM reporting systems, and Enterprise Resource Planning (ERP) systems like SAP and Warehouse Management Systems (WMS).

Responsibilities

• Oversee the receipt and shipment of controlled drug products, ensuring full compliance with DEA regulations.
• Perform biennial inventory and year-end stock assessments, handle ARCOS monthly reporting, and conduct cycle count inventory via the DEA website.
• Develop and implement training programs for staff on the proper handling of controlled substances and compliance requirements.
• Coordinate the destruction of expired or unneeded controlled substances with reverse distributors, adhering to DEA guidelines.
• Collaborate with compliance teams to remain current with evolving DEA regulations and ensure business processes meet regulatory standards.
• Evaluate and assess orders under the Suspicious Order Monitoring (SOM) program to identify and mitigate risks of diversion.
• Manage drug quotas, schedules, codes, and List I chemicals to maintain compliance with DEA standards.
• Ensure proper security measures for controlled substance storage and maintain accurate documentation in line with Good Documentation Practices (GDP).
• Support various special projects and tasks as assigned by management.

Benefits

• Health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans.
• Participation in a 401(k) plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: No Education Listed