Director, Quality Operations Distribution
About The Position
McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you. The Director of Quality Operations, Distribution is responsible for leading all quality-related activities for wholesale distribution, 3PL, national brands, and government operations. This role ensures compliance with regulatory standards, drives continuous improvement, and fosters a culture of quality across the organization. The Director will oversee strategic planning, process improvements, quality control systems, and team leadership while collaborating with supply chain, customer service, category management, and sales teams.
Requirements
- Bachelor's degree or higher in Engineering, Science, or related field.
- 10+ years in leadership roles within scientific fields or Quality Assurance in distribution or commercial manufacturing of medical devices/pharmaceuticals.
- Clear understanding of cGxPs.
- Experience leading FDA, Board of Pharmacy, and/or NABP inspections.
- Expertise in regulatory requirements for distribution QA (CFR 205, 820, 210, 211, DSCSA, Hazmat, Cold Chain).
- Strong verbal and written communication skills.
- Organizational, problem-solving, and decision-making abilities.
- Strategic thinking and change management skills.
- Must be authorized to work in the U.S.
- Sponsorship is not available for this position.
Responsibilities
- Ensure regulatory and operational standards are established, executed, and monitored within distribution centers.
- Oversee temperature monitoring and documentation for product storage areas.
- Lead investigations into complaints and CAPA for product and process quality issues, including diversion and illegitimate products.
- Prepare distribution centers for regulatory inspections and host external audits from suppliers and regulatory bodies.
- Develop and monitor KPIs, compile compliance reports, and provide recommendations for improvement.
- Act as a training resource for cGxP and ISO compliance; maintain up-to-date SOP training records.
Benefits
- Eligible for annual performance bonus and comprehensive benefits package including medical, dental, vision, 401(k), and paid time off.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Industry
Merchant Wholesalers, Nondurable Goods
Number of Employees
5,001-10,000 employees
