Compliance Manager, Business

The Compliance Manager is responsible for ensuring that Numed Pharma adheres to all federal, state, and local regulations governing pharmaceutical distribution, controlled substances, and compounding-related products. This role oversees licensing, DEA compliance, and Know Your Customer reviews and audits, and works closely with leadership, warehouse operations, regulatory agencies, and customers to maintain an audit-ready environment and ensure the integrity and security of the pharmaceutical supply chain.

The Compliance Manager is an in-person role based in Springboro, Ohio.

Key Responsibilities

• Oversee and maintain all wholesale distributor licenses and accreditations, controlled substance permits, and renewals across existing and new jurisdictions.
• Maintain a comprehensive licensing tracker with renewal dates, responsible parties, and required documentation and submit timely applications, renewals, and updates to state boards of pharmacies.
• Ensure facilities and personnel meet all licensing qualifications, including responsible person requirements.
• Ensure compliance with DEA regulations for procurement, storage, inventory, distribution, security, and recordkeeping of controlled substances.
• Monitor and report suspicious orders through the Suspicious Order Monitoring System.
• Serve as the primary contact during DEA inspections and maintain professional relationships with local DEA offices.
• Conduct Know Your Customer reviews for all vendors, customers, and 3PL partners prior to onboarding or shipment.
• Maintain documentation and risk assessments in accordance with DEA, FDA, and DSCSA expectations.
• Collaborate with Director of Operations to ensure 3PL customers and controlled substances/temperature sensitive products meet licensing, contractual, and recordkeeping requirements.
• Conduct periodic internal audits of licensing records, controlled substance logs, documentation, DSCSA data and documentation, 3PL recordkeeping, and SOP adherence.
• Lead inspection readiness activities and prepare required reports.
• Develop, update, and maintain SOPs related to compliance, security, controlled substance handling, and distribution processes.
• Monitor regulatory changes and provide timely updates to internal teams.
• Prepare compliance reports summarizing audit findings, risk indicators, and corrective actions.
• Provide compliance training for warehouse, operations, customer service, sales, and management teams.

Education, Experience, Knowledge and Skills:

• A bachelor’s degree in Pharmaceutical Sciences, Regulatory Affairs, or a related field, with an advanced degree preferred.
• At least five years of experience in compliance, quality assurance, or regulatory affairs in a pharmaceutical distribution environment.
• Strong knowledge of DEA, FDA, DSCSA, and state Board of Pharmacy regulations.
• Demonstrated ability to make decisions guided by strong business ethics and integrity.
• Able to handle highly sensitive and confidential information.
• Excellent written and oral communicator.
• Capable of solving complex business problems.
• Highly detail oriented.
• Ability to work well under pressure and manage multiple tasks simultaneously.
• High level of personal enthusiasm and self-motivation.
• Drive for results.
• Familiarity with ERP or WMS systems preferred.