Compliance Operations Lead - Controlled Substances

MCKESSON; Kansas City (MO); On-site; USD 83,000 - 139,000; Full time

Job summary

McKesson is seeking an Operations Specialist - Controlled Substances to oversee quality and compliance in storage, handling, and distribution of controlled substances within Distribution Centers. You will collaborate across functions to ensure adherence to DEA, FDA, and state requirements and drive continuous improvement across sites.

The role emphasizes leadership, cross‑functional collaboration, and inspections readiness, with onsite work at Kansas City, MO and Columbus, OH facilities.

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

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.

Skills

Quality Assurance

Regulatory affairs

Regulated distribution

Leadership

Pharmaceutical distribution

DEA/FDA inspections

Education

Bachelor's degree in a relevant field such as science, healthcare, quality/compliance, supply chain, or distribution operations

Advanced degree preferred

Job description

McKesson is seeking an Operations Specialist - Controlled Substances to oversee quality and compliance in storage, handling, and distribution of controlled substances within Distribution Centers. You will collaborate across functions to ensure adherence to DEA, FDA, and state requirements and drive continuous improvement across sites.

The role emphasizes leadership, cross‑functional collaboration, and inspections readiness, with onsite work at Kansas City, MO and Columbus, OH facilities.