Operations Specialist - Controlled Substances

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you. The Operations Specialist - Controlled Substances oversees quality and compliance activities related to the storage, handling, and distribution of controlled substances within Distribution Centers. The role ensures compliance with federal and state-controlled substance regulations through cross functional collaboration, leadership, decision making , training, and issue resolution, often without onsite supervision. Key Responsibilities - Manage site quality systems and processes related to the storage, handling, and distribution of controlled substances. - Ensure policies and procedures are in place for inventory control, documentation, reporting, investigations, training, and audits related to controlled substances. - Partner with Operations to managedaytodaydistribution center activities and ensure compliance with all applicable laws, regulations, and procedures. - Lead or approve controlled substance nonconformance investigations, track KPIs, drive continuous improvement initiatives, and supportadditionaldistribution centers as needed. - Leadinspectionreadiness initiatives, including mock audits and compliance training. - Serve as the primary interface with regulatory agencies (e.g., DEA) for inspections and regulatory inquiries. Minimum Job Qualifications : - Bachelor's degree in a relevant field such as science, healthcare, quality/compliance, supply chain, or distribution operations required. Advanced degree preferred. - Minimum of 5 years of experience in Quality Assurance, compliance, regulatory affairs or regulated distribution operations. - Minimum of 3 years of leadership experience, including direct people leadership, project leadership, or cross-functional process ownership. - Experience supporting regulated warehousing or distribution operations, including inventory control, investigations, audits, training, and quality system documentation. - Experience with pharmaceutical distribution, controlled substance compliance, and inspections by regulatory agencies such as DEA, FDA, or State Boards of Pharmacy preferred Specialized Knowledge/Skills - Thorough knowledge of federal controlled substances regulations (21 CFR Title 21, Chapter II, Parts 1300+) - Knowledge of applicable state-controlled substance laws preferred - Strong knowledge of 21 CFR 210, 211, and 820; ISO 13485 - Proven leadership, interpersonal, influence, and negotiation skills - Strong analytical andproblemsolvingabilities - Excellent written and verbal communication skills across organizational levels - Ability to useAIenabledtools and analytics to support controlled substance compliance monitoring, inventory anomaly detection, investigation trending, and KPI reporting, while ensuring all outputs are appropriately reviewed,validated, and compliant with regulatory, audit, and data integrity requirements. Working Conditions: - Distribution Center environment - Onsite role with locations in Kansas City,MOand Columbus, OH Travel Requirements: Willingness to travel a