Eric Humes - Dark Horse Consulting

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years of experience

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years at DHC

Eric

's Service Domains

CMC

Nonclinical

Clinical

Quality & Compliance

Business Analytics

Eric Humes is a Quality Assurance executive with more than 32 years of experience spanning biopharmaceutical sponsors, CROs, and independent consulting. His expertise encompasses GLP, GCP, cGMP, and pharmacovigilance systems, with a proven record of establishing and optimizing Quality Management Systems (QMS) that withstand global regulatory scrutiny. He has supported and led inspection readiness and management activities across FDA, EMA, MHRA, PMDA, and ANVISA, and has been directly involved in nine successful marketing applications across oncology, orphan/rare disease, cardiovascular, and biosimilar therapies.

Additionally, Eric has guided organizations through every stage of the product lifecycle. He has held C-suite and senior leadership positions at Agenus (MiNK Therapeutics, SaponiQx), Medpace, and ICON, where he built and led Quality organizations that supported biologics, cell and gene therapy, vaccines, and small molecules. His leadership has been instrumental in enabling nine successful marketing applications across diverse therapeutic areas, including oncology and rare diseases. His regulatory acumen is complemented by his longstanding role with the Society of Quality Assurance, where he developed and taught courses on CAPA systems, computerized data integrity, and FDA BIMO inspection readiness.

Eric specializes in establishing and scaling Quality Units that balance strategic vision with operational excellence. He has overseen enterprise-level QMS design and harmonization, driven continuous improvement initiatives, and strengthened vendor governance across CROs, CMOs, and technology providers. As a frequent industry speaker and educator, he has championed the role of Quality as a business enabler rather than a constraint.

A recognized expert in inspection management, Eric works with clients to build inspection-ready organizations through robust governance frameworks, risk-based oversight of vendors, and implementation of data-driven quality metrics. He emphasizes the creation of sustainable Quality Culture as the foundation for ensuring both regulatory compliance and successful product development.

Eric is deeply committed to cultivating a Quality Culture that fosters accountability, continuous improvement, and collaboration. By embedding inspection readiness into daily operations, he helps organizations not only meet regulatory expectations but also build trust with partners, patients, and regulators. His approach empowers small and virtual biopharma and cell/gene therapy companies to operate with the confidence and rigor of established enterprises.