Operations Specialist - Controlled Substances

McKesson•Kansas City, MO

8d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in a relevant field such as science, healthcare, quality/compliance, supply chain, or distribution operations required.
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.
Thorough knowledge of federal controlled substances regulations (21 CFR Title 21, Chapter II, Parts 1300+)
Strong knowledge of 21 CFR 210, 211, and 820; ISO 13485
Proven leadership, interpersonal, influence, and negotiation skills
Strong analytical and problem ‑ solving abilities
Excellent written and verbal communication skills across organizational levels
Ability to use AI ‑ enabled tools 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.

Nice To Haves

Advanced degree preferred.
Experience with pharmaceutical distribution, controlled substance compliance, and inspections by regulatory agencies such as DEA, FDA, or State Boards of Pharmacy preferred
Knowledge of applicable state-controlled substance laws preferred

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 manage day ‑ to ‑ day distribution 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 support additional distribution centers as needed.
Lead inspection readiness initiatives, including mock audits and compliance training.
Serve as the primary interface with regulatory agencies (e.g., DEA) for inspections and regulatory inquiries.