Tara Gooen Bizjak is an engineering officer in the United States Public Health Service. She is a Senior Science Policy Advisor in the Office of Policy for Pharmaceutical Quality, external policy. CDR Bizjak has been with the FDA for 16 years, focusing on drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. She started as a field investigator and transferred to CDER in 2007. She is a subject matter contact for quality metrics and quality culture, emerging technology and continuous manufacturing, and pharmaceutical quality systems. Prior to her current role, she was a branch chief in the area of drug manufacturing pre-approval inspections and a senior advisor in the Office of Regulatory Affair’s Office of Policy and Risk Management. CDR Bizjak is an ASQ (American Society for Quality) Certified Quality Engineer and received a B.S. in Chemical Engineering from Cornell University and a Masters in Biomedical Sciences from Rutgers University.