Senior Manager, DEA Compliance

Responsibilities

• Understands and interprets DEA regulations and directs the development and implementation of policies, procedures, and practices for compliance with applicable rules and regulations.
• Execute and operationalize strategies for obtaining and maintaining controlled substances quotas.
• Provide DEA compliance training to facility staff.
• Monitor all licensing requirements regarding the handling of controlled material.
• Oversee the applications (DEA250) for procurement quota.
• Monitor the use of DEA222 order forms for compliance with DEA requirements.
• Review cGMP documentation related to controlled substances.
• Oversees inventory accountability and reconciliation for controlled substances.
• Coordinates controlled drugs destructions in accordance with DEA regulations.
• Led and directs Anti-Diversion due diligence program to minimize diversion potential through audits, training, security programs and investigations.
• Remain current with industry practices/trends and regulatory agency expectations governing controlled substance handling and reporting, and supply chain security industry practices.
• Manage controlled substance handling to ensure DEA regulation compliance.
• Ensure proper security controls are in place for shipping and receiving controlled drugs.
• Participates in the development and implementation of methods, procedures and regulations necessary for the smooth operation of the business.

Requirements

• Bachelor's degree (or equivalent) and 8 years of experience with DEA Compliance Regulations of controlled substances or, in lieu of a Bachelors degree, 10 years of experience with DEA compliance.
• Must possess advanced knowledge and interpretation of DEA regulations and industry guidance’s, policies, and procedures pertaining to the DEA Controlled Substance and/or supply chain security.
• Experience in facilitating and executing compliance training events.
• Experience in facilitating a DEA Compliance work environment for production and distribution.
• Ability to coordinate multiple group efforts within the company to achieve objectives.
• Ability to perform computations such as percentages, ratios, and rates.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
• Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
• Possess organization skills, time management skills and attention to detail.
• Proficient in Microsoft Office.
• Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.
• Possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
• Exceptional attention to detail and excellent organizational skills.
• Able to accommodate up to 10% travel.