Quality Auditing

Michelle M. Holcomb is a seasoned quality professional with more than 30 years of expertise in biological and pharmaceutical manufacturing, specializing in compliance, quality systems, and regulatory auditing. With a career spanning leading organizations such as Boehringer Ingelheim Animal Health, Merial, Pfizer, and Zoetis, Michelle brings a proven track record of ensuring operational integrity across FDA, USDA/APHIS, CFIA, EU, and Latin and South American regulated markets.

 

Raised on a farm in Nebraska, Michelle’s early love of animals and passion for science inspired a lifelong dedication to quality in the animal health industry. Over three decades, she has built deep technical knowledge in biologics, pharmaceuticals, production processes, and global regulatory standards.

 

Michelle is formally trained as an auditor in both a drug products and raw materials, with extensive experience preparing sites for regulatory inspections, conducting supplier and contract-manufacturer audits, and leading quality system assessments. Her auditing expertise includes change control, deviations, CAPA, risk management, data integrity, material release, testing operations, and compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

 

Her career includes leadership roles such as Manager of Quality Systems, Manager of Third-Party Manufacturing, Manager of Compliance and Standards, and multiple positions overseeing Quality Operations teams in the U.S. and Canada. Michelle has led global process redesign initiatives, supported technology transfer, and guided organizations through significant compliance enhancements and regulatory engagements.

 

Known for her decisiveness, accountability, and ability to quickly build trust, Michelle excels at identifying risks, evaluating systems objectively, and translating complex quality requirements into actionable improvements. She brings a strong Lean Manufacturing background as a site Kaizen Leader, along with broad experience facilitating cross-functional collaboration to drive compliance, efficiency, and operational excellence. Michelle holds both a Master of Science and Bachelor of Science in Food Science & Technology from the University of Nebraska–Lincoln. Her analytical foundation, combined with decades of hands-on quality leadership, enables her to bring insight, fairness, and rigor to her auditing work.