QA Compliance Lead – Controlled Substances

McKesson; Columbus (OH); On-site; USD 83,000 - 139,000; Full time

Job summary

McKesson is seeking a QA Compliance Specialist - Controlled Substances to oversee quality and compliance across distribution centers. You will ensure adherence to federal and state regulations, lead investigations, and drive continuous improvement with cross-functional teams.

Based in Columbus, OH or Kansas City, MO, this on-site role requires 5+ years in quality/compliance and a track record of regulatory interactions with agencies such as DEA or FDA.

Qualifications

• Bachelor’s degree in science, healthcare, quality/compliance, supply chain, or distribution operations required.
• Minimum of 5 years 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 with 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 compliance

Leadership

Cross-functional collaboration

Analytical thinking

Investigations

Communication skills

AI-enabled tools usage

Education

Bachelor’s degree in a relevant field

Advanced degree preferred

Job description

McKesson is seeking a QA Compliance Specialist - Controlled Substances to oversee quality and compliance across distribution centers. You will ensure adherence to federal and state regulations, lead investigations, and drive continuous improvement with cross-functional teams.

Based in Columbus, OH or Kansas City, MO, this on-site role requires 5+ years in quality/compliance and a track record of regulatory interactions with agencies such as DEA or FDA.