Lead QA & Compliance - Controlled Substances

McKesson Corporation; Kansas City (MO); 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 activities for the storage, handling, and distribution of controlled substances within Distribution Centers. The role collaborates across functions, leads investigations, tracks KPIs, and supports multiple centers.

Onsite work locations include Kansas City, MO and Columbus, OH. Responsibilities include liaison with regulators (DEA/FDA), inspection readiness, and implementation of inventory

Qualifications

• Bachelor's degree in a relevant field; advanced degree preferred.
• Minimum 5 years in quality assurance, compliance, regulatory affairs or regulated distribution operations.
• Minimum 3 years of leadership experience (people, projects or cross-functional ownership).
• Experience with regulated warehousing/distribution operations, inventory control, investigations, audits, training, and quality system documentation.
• Experience with pharmaceutical distribution, controlled substances compliance, and inspections by regulatory agencies (DEA, FDA, etc.) preferred

Responsibilities

• Manage site quality systems and processes for storage, handling, and distribution of controlled substances.
• Ensure policies for inventory control, documentation, reporting, investigations, training, and audits are in place.
• Partner with Operations on day-to-day distribution center activities and ensure regulatory compliance.
• Lead investigations, track KPIs, drive continuous improvement, support other centers as needed.
• Lead inspection readiness initiatives, including mock audits and compliance training.
• Serve as primary interface with regulatory agencies (DEA, etc.) for inspections and inquiries.

Skills

Quality Assurance

Compliance

Regulatory affairs

Leadership

Inventory control

Audits

Training

Data analytics

DEA/FDA knowledge

Education

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

Tools

AI analytics tools

Regulatory databases

Job description

McKesson is seeking a QA Compliance Specialist - Controlled Substances to oversee quality and compliance activities for the storage, handling, and distribution of controlled substances within Distribution Centers. The role collaborates across functions, leads investigations, tracks KPIs, and supports multiple centers.

Onsite work locations include Kansas City, MO and Columbus, OH. Responsibilities include liaison with regulators (DEA/FDA), inspection readiness, and implementation of inventory