System One | Controlled Substance Compliance Manager - ...

Job Title: Controlled Substances Compliance Manager Location: South Brunswick, NJ Salary: $120k - DH We are seeking a Controlled Substances Compliance Manager (DEA / SOMS) to join a fantastic team! Job Responsibilities: Receiving & Shipping: Oversee the receipt and shipment of controlled drug products, ensuring full compliance with DEA regulations. Inventory Management: Perform biennial inventory and year-end stock assessments, handle ARCOS (Automation of Reports and Consolidated Orders System) monthly reporting, and conduct cycle count inventory via the DEA website. Training: Develop and implement training programs for staff on the proper handling of controlled substances and compliance requirements. Destruction Coordination: Coordinate the destruction of expired or unneeded controlled substances with reverse distributors, adhering to DEA guidelines. Regulatory Compliance: Collaborate with compliance teams to remain current with evolving DEA regulations and ensure business processes meet regulatory standards. Suspicious Order Monitoring (SOM) Program: Evaluate and assess orders under the Suspicious Order Monitoring (SOM) program to identify and mitigate risks of diversion. Drug Quota & Schedule Management: Manage drug quotas, schedules, codes, and List I chemicals to maintain compliance with DEA standards. Security & Documentation: Ensure proper security measures for controlled substance storage and maintain accurate documentation in line with Good Documentation Practices (GDP). Additional Projects: Support various special projects and tasks as assigned by management. Qualifications: Experience: Previous experience in supply chain management within regulated industries, especially handling controlled substances in pharmaceutical manufacturing, distribution, or healthcare. Knowledge of DEA Regulations: Deep understanding of DEA regulations, including SOM programs, drug quota management, and documentation requirements. Regulatory Compliance Experience: Familiarity with DEA cyclic inspections and audit management processes. Organizational & Team Management: Strong ability to manage and lead teams, prioritize tasks, and maintain structured organizational processes. Documentation Expertise: Experience in Good Documentation Practices (GDP) and maintaining accurate records for controlled substances. Technical Proficiency: Proficient in Microsoft Office and familiar with ARCOS, SOM reporting systems, and Enterprise Resource Planning (ERP) systems like SAP and Warehouse Management Systems (WMS). Selling Points: Opportunity to work in a highly regulated environment: Ensure compliance with DEA standards and contribute to maintaining industry-leading regulatory practices. Be a key part of a growing company: Be part of a team that has experienced rapid growth over the past 10 years, emphasizing compliance and operational excellence in all aspects of its business. Exposure to challenging, high-responsibility tasks: Gain valuable experience in controlled substance management, dealing with complex and critical responsibilities in a highly regulated industry. Keywords: DEA Compliance Manager, Suspicious Order Monitoring (SOM), Controlled Substance Compliance, DEA Regulations, ARCOS Reporting, SOM Program, Controlled Drug Management, Pharmaceutical Supply Chain, Drug Quota Management, DEA Inventory Reporting, Good Documentation Practices (GDP), DEA Cyclic Inspections, Controlled Substance Storage Security, Drug Schedules, ERP Systems (SAP), Supply Chain Management in Pharma, Reverse Distributors, Drug Enforcement Administration, (DEA), m SOMS, Sourcing, Ordering, Manufacturing, Shipping System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Created: 2024-11-27