Quality Assurance Auditor

McKesson•Richmond, VA

4d•$83,300 - $138,800•Hybrid

About The Position

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. Job Summary: 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.

Requirements

4+ years of relevant experience
Bachelor's degree in Science or related experience
2+ years of experience conducting quality audits within a highly regulated environment, including medical device, pharmaceutical, supplier qualification, quality systems, GMP/cGMP, or related regulatory compliance audits.
Total 4 years of professional experience in auditing, quality assurance, supplier quality, compliance, manufacturing quality, or other related quality functions.
Demonstrated ability to communicate audit observations, compliance findings, and quality concerns professionally and diplomatically while working on-site with supplier leadership and quality teams, fostering productive discussions and driving resolution of complex issues.
Experience performing supplier, quality system, cGMP, GMP, pharmaceutical, medical device, or contract manufacturing audits in a highly regulated environment.
Strong knowledge of FDA regulations, 21 CFR Part 820, current Good Manufacturing Practices (cGMP), ISO 13485, and quality management systems.
Experience evaluating supplier qualification programs, quality systems, manufacturing operations, and compliance processes.
Ability to identify quality risks, assess regulatory compliance, and recommend practical corrective actions.
Demonstrated experience writing audit reports, documenting findings, and presenting recommendations to stakeholders.
Strong project management and organizational skills with the ability to independently manage multiple audits and priorities.
Ability to travel extensively and work effectively in manufacturing, laboratory, warehouse, and office environments.

Nice To Haves

ISO 13485 Lead Auditor Certification
ASQ Certified Quality Auditor (CQA), Lead Auditor certification, or similar quality certification preferred.
Spanish bilingual capability a plus.
Bachelor's degree in chemistry, biology, microbiology, engineering, life sciences, or a related technical discipline preferred.

Responsibilities

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, to conduct on-site supplier audits and assessments.