Horace Gumba
Quality Manager
Quality Manager-Therapy Acceleration Laboratory (TAL)
I'm currently the Quality Manager within the TAL, WIMM at the University of Oxford Medical Sciences Division, where I oversee quality operations supporting advanced translational and molecular diagnostic laboratory programmes.
Throughout my career, I have developed and implemented robust Quality Management Systems (QMS) aligned with international regulatory and accreditation standards including ISO 15189, ISO 17025, Good Clinical Laboratory Practice (GCLP), Good Clinical Practice (GCP), Human Tissue Authority (HTA), CLIA, and GDPR requirements. I have extensive expertise in regulatory compliance, laboratory accreditation, internal and external audit management, risk and CAPA management, validation and verification programmes, quality metrics reporting, and continual improvement strategies within multidisciplinary laboratory settings.
With over 14 years’ experience in biomedical research and clinical trials, I specializes in designing, implementing and leading Quality Management Systems (QMS) that meet the highest international standards, including ISO 15189, GCLP, GCP, HTA and GDPR. I am an expert user of electronic QMS platforms (iPassport and Q-Pulse), leads internal and external audits, manages regulatory inspections, drives validation and verification programmes, and cultivates a culture of continuous improvement across multidisciplinary laboratory teams.
At the University of Oxford, I have played a leading role in establishing and strengthening quality governance and frameworks for the Oxford Cancer Translational Laboratories and Oxford Molecular Diagnostic Centre. My work has included the successful implementation of GCLP-compliant systems, coordination of regulatory inspections and sponsor audits, development of electronic QMS platforms using iPassport, and leadership of quality improvement initiatives that support operational excellence and regulatory readiness. I have also worked closely with national and international regulatory agencies and accreditation bodies, including UKAS, MHRA, FDA, and the European Medicines Agency. I played a central role in strengthening quality governance. As Quality Assurance Manager, I developed and implemented GCLP- and ISO 15189-compliant systems for the Oxford Cancer Translational Laboratories and Oxford Molecular Diagnostic Center, securing GCLP accreditation in August 2025.
I hold an MSc in Quality Management in Biomedical Science from the University of Greenwich and a BSc in Biomedical Science from Maseno University. I am a member of several professional bodies, including the American Society for Quality, the Research Quality Association, the Africa Society for Laboratory Medicine, and the Society of Quality Assurance.
In addition to my operational and leadership responsibilities, I have also contributed to peer-reviewed publications focused on laboratory quality systems, electronic quality management implementation, and GCLP integration within biomedical research laboratories. My work reflects a strong commitment to advancing quality, regulatory compliance, and continuous improvement in clinical and translational research environments.