Lead QA Compliance Specialist, Controlled Substances

MCKESSON Careers; 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 regulatory activities within Distribution Centers, ensuring compliance with federal and state regulations across storage, handling, and distribution.

This onsite role in Columbus, OH (and Kansas City, MO) partners with Operations to lead investigations, trainings, audits and inspections (DEA/FDA), driving continuous improvement and risk mitigation in controlled substance operations.

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

Leadership

Quality Assurance

Regulatory affairs

Controlled substances

Audits

DEA/FDA inspections

Analytical skills

Communication

Education

Bachelor’s degree in science/healthcare/quality/compliance

Job description

McKesson is seeking a QA Compliance Specialist - Controlled Substances to oversee quality and regulatory activities within Distribution Centers, ensuring compliance with federal and state regulations across storage, handling, and distribution.

This onsite role in Columbus, OH (and Kansas City, MO) partners with Operations to lead investigations, trainings, audits and inspections (DEA/FDA), driving continuous improvement and risk mitigation in controlled substance operations.