Controlled Substances QA & Compliance Lead

McKesson’s Corporate; Missouri; On-site; USD 83,000 - 139,000; Full time

Job summary

McKesson is seeking a qualified leader to oversee quality systems for the storage, handling, and distribution of controlled substances. The role requires a strong background in regulatory affairs and distribution operations, with emphasis on compliance and inspections.

You will partner with Operations and interact with agencies such as DEA and FDA to ensure audit readiness and continuous improvement. Minimum 5 years in QA/compliance and 3 years in leadership are expected; a bachelor’s degree is

Qualifications

• Bachelor’s degree in science, healthcare, quality/compliance, supply chain, or distribution operations is required.
• Advanced degree is preferred.
• 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 and regulated substance inspections by 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 for inventory control, documentation, reporting, investigations, training, and audits.
• 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

Leadership

Regulatory knowledge

Analytical skills

Communication skills

AI analytics usage

Education

Bachelor’s degree

Advanced degree

Tools

Regulatory software

Job description

McKesson is seeking a qualified leader to oversee quality systems for the storage, handling, and distribution of controlled substances. The role requires a strong background in regulatory affairs and distribution operations, with emphasis on compliance and inspections.

You will partner with Operations and interact with agencies such as DEA and FDA to ensure audit readiness and continuous improvement. Minimum 5 years in QA/compliance and 3 years in leadership are expected; a bachelor’s degree is