Kath Williams

Senior Consultant, GxPAssure

Dr. Kath Williams is a highly experienced Quality Assurance and GxP compliance professional with more than 25 years’ specialist experience within the pharmaceutical and pharmaceutical research sectors. As a Senior Consultant at GxPAssure and Director of KEW Quality Consulting Ltd, she provides expert auditing, compliance oversight, and strategic QA support to global organisations, SMEs, CROs, and specialist service providers.

A former MHRA Senior GCP Inspector, Kath brings deep regulatory insight and extensive hands‑on experience conducting GCP, GVP, GLP, and clinical/analytical laboratory audits. Her expertise spans for‑cause investigations, due‑diligence audits, investigator site assessments, Phase 1 unit reviews, vendor/CRO evaluations, niche technology audits, and comprehensive data integrity reviews. She is recognised for her strong analytical capability, critical thinking, and decisive problem‑solving skills.

Kath has successfully developed and implemented risk‑based global audit strategies, managed QA departments, and led large‑scale inspection readiness programmes. She has supported numerous organisations through MHRA, EMA, and other regulatory authority inspections, and is well regarded for her engaging training style and her ability to mentor auditors at all levels.

Holding a PhD in Analytical Chemistry and an MSc in Analytical Sciences from the University of Hull, Kath is also a Chartered Chemist (CChem) and long‑standing Member of the Royal Society of Chemistry (MRSC). She has been an active member of the Research Quality Association (RQA) since 2002 and previously served as Chair of the RQA Board. Her ongoing professional development covers a broad spectrum of GxP compliance, data integrity, EU/UK regulatory requirements, and quality systems leadership.