QA Compliance Lead: Controlled Substances & Regs

McKesson; 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 in the storage, handling, and distribution of controlled substances within Distribution Centers. The role requires collaboration across functions, leadership, and strong regulatory knowledge.

Key duties include managing quality systems, preparing for inspections (DEA/FDA), and driving continuous improvement across multiple distribution centers.

Qualifications

• Bachelor’s degree in science, healthcare, quality/compliance, supply chain, or distribution operations.
• Minimum of 5 years in QA, compliance, regulatory affairs, or regulated distribution operations.
• Minimum of 3 years of leadership experience.
• Experience with regulated warehousing, inventory control, audits, training, and quality system documentation.
• Experience with pharmaceutical distribution and DEA/FDA/state board inspections preferred.

Responsibilities

• Manage site quality systems and processes related to the storage, handling, and distribution of controlled substances.
• Ensure policies for inventory control, documentation, reporting, investigations, training, and audits.
• Partner with Operations to manage day-to-day distribution center activities and ensure compliance.
• Lead or approve nonconformance investigations, track KPIs, drive improvements, and support additional centers.
• Lead inspection readiness initiatives, including mock audits and compliance training.
• Serve as primary interface with regulatory agencies for inspections and inquiries.

Skills

Leadership

Quality Assurance

Regulatory compliance

Cross-functional collaboration

Inventory control

Audits

Training

Process documentation

Regulatory inspections

Education

Bachelor’s degree

Advanced degree preferred

Job description

McKesson is seeking a QA Compliance Specialist - Controlled Substances to oversee quality and compliance in the storage, handling, and distribution of controlled substances within Distribution Centers. The role requires collaboration across functions, leadership, and strong regulatory knowledge.

Key duties include managing quality systems, preparing for inspections (DEA/FDA), and driving continuous improvement across multiple distribution centers.