Mantell Associates is partnered with a fast growing generic pharmaceutical company, who is seeking a Director/VP, DEA Compliance. 

Director/VP, DEA Compliance – Responsibilities:

• Direct and manage the Controlled Substance & Safety department on all day-to-day activities, as well as monthly, quarterly and annual responsibilities of the department to ensure compliance
• Oversee the daily tracking of in-house inventory accounting for all controlled substance materials on site
• Ensure accurate record keeping and reporting through hardcopy and electronic logbooks/spreadsheets
• Review and Analyze the Compilation of Purchases/Receiving and Sales/Shipping paperwork
• Offer advice and guidance to all departments to insure compliance with DEA/NYS/OSHA regulations and procedures
• Establish the auditing and monitoring process of the requirements set forth in the controlled substance policies and procedures pertaining to the records required to be kept during the receipt, storage, manufacturing, distribution, and disposal of controlled substances
• Oversee and maintain all security measures including Vault, Cage, Safes, Cameras, Motion Sensors, Door Contacts, Alarm Systems, Card Access System, Lock systems, Gates, and Fencing
• Review and revise all SOP’s, design and oversee training for all departments as is relates to Controlled Substances and Security
• Head internal investigation efforts, recommend corrective actions, and ensure routine trainings are performed as required
• Serve as the lead contact in interfacing with Federal and State agencies as required on issues relating to reporting requirements, inspections, and other miscellaneous requests
• Review and submit reports to DEA/NYS/State Agencies and work with each to resolve questions and concerns
• Plan, organize, and work to solve complex problems and respond to agency requests timely and accurately
• Work independently to resolve departmental issues while also collaborating with others to ensure company-wide compliance and understanding

Director/VP, DEA Compliance – Requirements:

• Master’s degree in science or related discipline with 10+ years of pharmaceutical controlled substance experience in the manufacturing industry
• Prior experience working for the DEA
• 3+ years of auditing, compliance and/or process management
• 2+ years Security, Law Enforcement or Investigatory experience preferred
• 5+ years managing a team

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +1 (786) 485 1298.

Tagged as: Quality, Regulatory