Ernest Bizjak U.S. FDA
Ernest Bizjak U.S. FDA Compliance Officer/Team Leader, OMQ, OC, CDER
Ernest Bizjak joined the U.S. FDA in June 2001 and began as an Investigator in the New Jersey District - North Brunswick Resident Post, primarily focusing on drug manufacturing/CGMP inspections. After a brief two and half year transfer to the Detroit District – Indianapolis Resident Post, he became a Drug Specialist in the Baltimore District in February 2008. He achieved Level III/Pharmaceutical Inspectorate certification in July 2010. In February 2012, he accepted a Compliance Officer position in the Baltimore District and handled many complex cases for all commodities regulated by FDA and continued to participate in domestic and foreign inspections whenever possible. In September 2018, he left ORA and joined CDER/Office of Compliance/Office of Manufacturing Quality as a Compliance Officer. In September 2021, he became a Team Leader providing support and guidance to a group of Compliance Officers. Ernie graduated from the University of Wisconsin – Madison with a BS degree in Pharmaceutical Science (Go Badgers!).