The posting
Our BusinessAdare 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 CultureWhen 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 DEA Compliance Specialist Location Vandalia, OH Summary The DEA Compliance Specialist manages federal regulatory compliance for handling, storing, manufacturing, and distributing controlled substances. The Specialist will oversee DEA reporting, inventory control, form coordination and submittal, year-end reconciliation activities, as well as research, implementation, and maintenance of security protocols. The DEA Compliance Specialist will also be a key liaison for Drug Enforcement Administration audits in partnership with the Site Quality and Supply Chain teams. Responsibilities
Understand and interpret DEA regulations and identifies areas of opportunity to improve policies, procedures, and practices for compliance with applicable rules and regulations; implement approved improvement plans. Manage monthly, quarterly and annual reporting, including accurate DEA ARCOS transactions and support of quota management for scheduled drugs. Coordinate, complete and submit required DEA Forms such as DEA222’s for compliance with DEA requirements. Assess site security measures in accordance with DEA guidelines, make recommendations for improvement where needed; implement approved plans. Serves as a key, at times the primary, point of contact for DEA and state-controlled substance regulatory inspections. Ensure proper security controls are in place for shipping and receiving controlled drugs. Review cGMP documentation related to controlled substances. Oversee secure destruction processes, coordinates with local DEA offices, and processes DEA Form 41 documentation. Oversee physical inventory accountability and reconciliation for controlled substances, including end-of-year reconciliation practices. Manage controlled substance handling to ensure DEA regulation compliance. Monitor all licensing requirements regarding the handling of controlled material. Train manufacturing and warehouse personnel on compliant handling, logging, and chain-of-custody protocols. Manage, execute, and support audit program to confirm and proactively ensure compliance. Lead 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. Other duties as assigned.
Experience, Education, and Skills Required
Bachelor’s degree and 3+ years of regulatory compliance or operations experience within an FDA- or DEA-regulated pharmaceutical environment (CDMO/CMO experience preferred), or an equivalent combination of education and work experience with acquired transferrable skills Knowledge and interpretation of DEA regulations and industry guidance’s, policies, and procedures pertaining to the DEA Controlled Substance and/or supply chain security. Previous experience working directly with regulatory agency(ies), or in law enforcement Meticulous record-keeping, and ability to research, interpret, and implement regulatory requirements High attention to detail, strong cross-functional communication, and sound audit-management capabilities. Ability to work effectively in high pressure situations
Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. PRINCIPALS ONLYNO AGENCIES OR THIRD PARTIES
