Controlled Substances Compliance Manager

JOB FUNCTION: Scientific
JOB TYPE: Direct Hire
LOCATION: Woodbridge, NJ
COMPENSATION: $125k
REMOTE / ONSITE: Onsite
POSTED: Nov 22, 2024

Our client, a privately-owned company specializes in the distribution and wholesaling of prescription medications. They serve long-term care pharmacies, standalone retail pharmacies, large chains, and medical facilities, with a commitment to superior value, unmatched quality, and unwavering reliability, enhancing the healthcare supply chain. They are in search of a detail-oriented Controlled Substances Compliance Manager who will be responsible for maintaining compliance with DEA regulations and managing the handling and distribution of controlled substances.

Salary/Hourly Rate:

$125,000

Position Overview:

The ideal Controlled Substances Compliance Manager candidate will have experience in warehouse management within the regulated pharmaceutical industry and a strong understanding of federal, state, and local laws governing controlled substances. The Controlled Substances Compliance Manager maintain accurate records of all incoming and outgoing shipments of controlled substances. Complete required DEA documentation, such as quota applications, inventories, destruction, and shipping forms.

Responsibilities of the Controlled Substances Compliance Manager:

  • Inventory Management: Monitor inventory levels, conduct regular physical inventory counts, and reconcile discrepancies. Coordinate with the procurement team to ensure adequate stock levels are maintained
  • Compliance and Security: Ensure compliance with all relevant laws, regulations, and company policies governing the handling and distribution of controlled substances, including DEA regulations. Implement security protocols to prevent theft, diversion, and unauthorized access to controlled substances
  • Inspections and Quality Assurance: Conduct inspections of incoming shipments to verify product quality and compliance with specifications. Prepare for DEA inspections of the facility and collaborate with Facility Management to assess and improve internal security systems
  • Training and Development: Understand the obligations imposed upon DEA registrants to train, mentor, and develop staff, as well as the basic requirements of FDA

Qualifications for the Controlled Substances Compliance Manager:

  • Minimum 3 to 5 years of experience in a warehouse management role within the regulated pharmaceutical or healthcare industry, with a track record in handling and distributing controlled substances
  • In-depth understanding of DEA regulations and other relevant federal, state, and local laws governing controlled substances
  • Familiarity with FDA requirements for controlled substances
  • Strong organizational and management skills to maintain accurate records, coordinate inventory levels, and ensure compliance with legal requirements
  • Ability to prioritize tasks, manage a team, and implement security protocols
  • Proficiency in common WMS, including Microsoft Office, SAP, and other warehouse management software
  • Familiarity with ARCOS (Automation of Reports and Consolidated Orders System) and SOM (State-run Online Ordering and Reporting System) reporting tools
  • Knowledge of security protocols and measures to prevent theft, diversion, and unauthorized access to controlled substances
  • Strong problem-solving skills to address discrepancies in inventory counts and efficiently resolve issues related to controlled substances handling

Education Requirements:

  • Bachelor’s degree in a related field, such as Pharmacy, Pharmaceutical Sciences, or a related regulatory discipline is required

Benefits:

  • Competitive and Comprehensive benefits package offered

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As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO

Position ID: 152128