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 storage, handling, and distribution compliance across Distribution Centers in Columbus, OH and Kansas City, MO. You will lead quality systems, investigations, and training to ensure regulatory adherence.

Role requires 5+ years in QA/compliance, 3+ years in leadership, and experience with regulated warehousing and inspections by DEA, FDA or state boards.

Qualifications

• Bachelor's degree in science, healthcare, quality/compliance, supply chain or distribution operations.
• Minimum 5 years in Quality Assurance, compliance, regulatory affairs or regulated distribution operations.
• Minimum 3 years of leadership experience including people leadership or cross-functional ownership.
• Experience with regulated warehousing/distribution, including inventory control, investigations, audits, and quality systems.
• Experience with pharmaceutical distribution and inspections by DEA, FDA or State Boards preferred.

Responsibilities

• Manage site quality systems and processes related to storage, handling, and distribution of controlled substances.
• Ensure policies and procedures for inventory control, documentation, reporting, investigations, training, and audits.
• Collaborate with Operations to manage day-to-day DC activities and ensure regulatory compliance.
• Lead or approve investigations of nonconformance, track KPIs, and support other distribution centers.
• Lead inspection readiness initiatives, including mock audits and training.

Skills

Leadership

Regulatory knowledge

Quality Assurance

Analytics

Documentation

Cross-functional collaboration

Communication

Education

Bachelor's degree in a relevant field

Advanced degree preferred

Job description

McKesson is seeking a QA Compliance Specialist - Controlled Substances to oversee storage, handling, and distribution compliance across Distribution Centers in Columbus, OH and Kansas City, MO. You will lead quality systems, investigations, and training to ensure regulatory adherence.

Role requires 5+ years in QA/compliance, 3+ years in leadership, and experience with regulated warehousing and inspections by DEA, FDA or state boards.