Dr. Meshack Odenyo

Dr. Meshack Oiro Odenyo is a seasoned pharmaceutical regulatory affairs and quality assurance leader with over 18 years of experience across Africa. He has built strong expertise in Good Manufacturing Practices (GMP), regulatory systems strengthening, pharmaceutical quality assurance, and product lifecycle management, contributing to the registration and oversight of more than 285 products. His career has included roles such as GMP Auditor for CHMP, QMS Consultant for Mac’s Pharmaceuticals, Technical Advisor with USAID, and contributions to WHO Prequalification, vaccine Emergency Use Authorization, and local manufacturing initiatives with UNIDO.

Dr. Odenyo holds advanced training in biotechnology and industrial pharmacy, including a master’s degree from Purdue University, and is currently pursuing a PhD in Biotechnology Innovation and Regulatory Science. His core competencies include participation in numerous local and international GMP inspections and pharmaceutical audit processes involving national medicines regulatory authorities in Africa and global regulatory frameworks. He has also worked closely with the Pharmacy and Poisons Board and WHO on Global Benchmarking Tool (GBT) assessments and the review of national pharmaceutical regulatory guidelines toward Maturity Level 3 compliance. In addition, he serves as an Adjunct Faculty member at the School of Pharmacy, Mount Kenya University, where he supports training in GMP, pharmaceutical technology, and regulatory compliance. His broad regulatory and production experience strengthens Kenya BioVax Institute’s mission to build a robust, globally competitive vaccine manufacturing ecosystem.