Quality Assurance Auditor

McKesson; Arizona; On-site; USD 102,000 - 109,000; Full time

Benefits offered by this job

PTO 16 days

Personal holidays

Fixed holidays

401(k) matching

Medical benefits

Wellness programs

Job summary

McKesson is seeking a Quality Assurance Auditor to lead supplier audits across the United States and internationally, ensuring FDA, cGMP, ISO standards, and McKesson quality requirements are met. The role requires extensive travel and collaboration with cross-functional teams to improve supplier performance and regulatory compliance.

The position supports supplier qualification, maintains audit records, and drives continuous quality improvements within McKesson Brands.

Qualifications

• 4+ years of relevant experience.
• Experience with FDA regulations (21 CFR Part 820) and GMP/cGMP.
• Experience performing supplier and quality system audits in regulated environments.

Responsibilities

• Conduct on-site supplier quality audits (domestic and international).
• Evaluate quality management systems and manufacturing processes.
• Prepare audit reports with observations and recommendations.

Skills

Quality audits

FDA regulations

cGMP

ISO 13485

Supplier quality

Audit reporting

Travel 75%

Cross-functional collaboration

Education

Bachelor's degree in Science

ISO 13485 Lead Auditor Certification

Job description

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.

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.

Key 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.

Compensation & Benefits

McKesson offers a competitive compensation and benefits package designed to attract and reward top talent. The expected base salary range for this position is $102,000 to $109,000 annually, depending on experience, skills, geographic location, and other job‑related factors.

In addition to base salary, this position is eligible for participation in the company's Annual Incentive Plan (AIP) with a target bonus opportunity of 5% of base salary, subject to plan terms and company performance.

• 16 days of Paid Time Off (PTO)
• 5 Personal Holidays annually
• 7 Fixed Holidays
• 401(k) with company matching contributions
• Medical, dental, and vision benefits
• Health benefits effective beginning the month following hire
• Additional wellness, financial, and professional development resources

Minimum Requirements

4+ years of relevant experience

Education/Training/Certification

• Bachelor's degree in Science or related experience
• ISO 13485 Lead Auditor Certification - Preferred

Preferred Critical Skills

• 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.

Additional Skills

• 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.

Work Environment/Physical Demands

• Will be working, standing, walking in various manufacturing areas.
• Time spent in home office conducting computer based administrative tasks.

Our Base Pay Range for this position

$83,300 - $138,800

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category.

For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities.

If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) [e-mail] or (Canada) [e-mail]. Resumes or CVs submitted to this email box will not be accepted.

Join us at McKesson!