Serge Wiyalika

Serge Wiyalika is an accomplished Quality Assurance Manager at Microbiologics, Inc. since March 2021, overseeing the implementation and maintenance of quality systems in compliance with regulatory standards such as 21 CFR Part 820, ISO 13485, and CE mark conformity. With extensive experience in quality and regulatory roles, Serge has served as a Quality and Regulatory Associate II at Summit Biosciences Inc., where responsibilities included overseeing pharmaceutical development and reviewing cGMP documentation. Prior experience includes quality assurance and engineering roles at Aquabiliti, regulatory coordination at U.S. IOL, Inc., and a strong educational background with a Master’s degree in Regulatory Science from Johns Hopkins University and a Bachelor’s degree in Science from Portland State University. Active membership in the Regulatory Affairs Professionals Society (RAPS) underscores Serge's commitment to the field.