Quality Assurance Auditor

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. Join Our Team and Help Shape the Quality Behind McKesson Brands Are you passionate about quality, compliance, and building trusted supplier relationships? McKesson is seeking a Quality Assurance Auditor to play a critical role in the continued growth and success of our McKesson Brands business. In this highly visible role, you'll travel extensively to supplier manufacturing facilities across the United States and internationally, partnering directly with potential and existing suppliers to evaluate quality systems, assess manufacturing capabilities, and ensure compliance with industry regulations and McKesson quality standards. Your expertise will directly influence supplier qualification decisions that protect patients, support regulatory compliance, and help bring high-quality healthcare products to market. This is an exciting opportunity for a quality professional who enjoys travel, values relationship building, thrives in highly regulated environments, and wants to make a meaningful impact across a growing global supplier network.

The Quality Assurance Auditor supports the qualification, approval, and ongoing oversight of domestic and international suppliers that manufacture products for McKesson Brands. This role is responsible for conducting supplier quality audits, evaluating quality systems and manufacturing controls, and assessing compliance with FDA regulations, current Good Manufacturing Practices (cGMP), ISO standards, and McKesson quality requirements. Working cross-functionally with quality, sourcing, regulatory, and supplier partners, the auditor helps ensure that suppliers have the systems, processes, and controls necessary to consistently deliver safe, effective, and compliant products. This role requires extensive travel and direct interaction with supplier leadership and quality teams to drive continuous quality improvement and supplier performance.

Conduct comprehensive on-site audits of domestic and international supplier manufacturing facilities to assess compliance with FDA regulations, cGMP requirements, ISO standards, and McKesson quality expectations. Support the supplier qualification and requalification audit program by planning, coordinating, and executing audits in accordance with established schedules and quality requirements. Evaluate supplier quality management systems, manufacturing processes, documentation practices, validation programs, corrective and preventive actions (CAPA), and overall regulatory compliance. Identify quality, compliance, and operational risks and prepare detailed audit reports that clearly communicate observations, findings, and recommendations. Partner with supplier quality teams and internal stakeholders to monitor corrective actions and ensure timely resolution of audit findings. Collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, Sourcing, and Product Development to support supplier approval and ongoing supplier performance management activities. Maintain current knowledge of applicable FDA regulations, cGMP requirements, industry standards, and emerging quality system expectations. Represent McKesson professionally while building productive relationships with suppliers and external partners. Travel approximately 75% , primarily throughout North America with occasional international travel,