Senior Manager, DEA Compliance

Our Business Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines. By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.” Our Culture When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space. In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day. Why Come to Adare? Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth. We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage. Position Senior Manager, DEA Compliance Location Vandalia, Ohio Summary The Senior Manager DEA Compliance will implement and maintain policies; provide input into strategy policies and practices for compliance with DEA Controlled Substance regulations, requirements, and expectations for both the Vandalia and Philadelphia locations. The Senior Manager will support development and execution of quota strategies based on current DEA regulations and practices. 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. * Coordination of controlled drugs destructions in accordance with DEA regulations. * Manages, executes, and supports audit program to confirm and proactively ensure compliance. * Leads and directs Anti-Diversion due diligence program to minimizes 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. * Respects policies, procedures and regulations in force in the company. * Completes assigned tasks in a safe manner and in a constant state of alertness. * Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code * Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. * Other duties as assigned. Required Skills and Experience * 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. * Must 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. * Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. * Exceptional attention to detail and excellent organizational skills. * Ability to accommodate up to 10% travel.