CAPT Tara Gooen Bizjak, MBSci, CQE, CQIA
EPAC Readiness Subcommittee Vice Chair
CAPT Bizjak is a chemical engineer with the Food and Drug Administration in Silver Spring, MD. CAPT Bizjak is the Director of the Manufacturing Guidance and Policy Staff in the Center for Drug Evaluation and Research, Office of Compliance, Office of Manufacturing Quality. In this role, she manages a policy staff of technical experts, regulatory counsels, and writer/editors and leads the development of science- and risk-based, patient-focused policies, standards, and guidance related to pharmaceutical manufacturing quality enforcement. She is a 20-year veteran of FDA, starting in the field as an investigator conducting pharmaceutical manufacturing inspections.
CAPT Bizjak is a current Certified Quality Engineer and Certified Quality Improvement Associate with the American Society of Quality. After working as a civilian with FDA for 6 years, she commissioned in the USPHS in 2009 to deploy and continue a career in public service. CAPT Bizjak graduated from Cornell University with a bachelor of science in chemical engineering and Rutgers University with a Masters in Biomedical Sciences. She joined the Regional Incident Support Team for the National Capital Region in 2010 and was the Deputy Team Commander (Training) from 2012-2019. In 2019-2020, she joined the National Incident Management Team A as a Deputy Team Commander. She has deployed in multiple roles for 18 different incidents/events, though primarily IMT Operations, and is the first USPHS officer credentialed as an HHS/ASPR Operations Section Chief (2018), as well as certified as a mentor/evaluator for the Operations role. Her most memorable deployments are the 2017 Maria/Irma Hurricane Response (Deputy Operations SC), 2018 President George H. Bush Funeral (Operations SC), and 2020 COVID-19 Repatriation (National Operations SC).
CAPT Bizjak is a third year as voting member of the EPAC. She is returning as EPAC Readiness Subcommittee Vice Chair (member since 2017, information lead since 2018, chair from mid-2021 to 2022, vice-chair from 2021-mid 2021). CAPT Bizjak was also the first engineer category representative on the Commissioned Corps Women’s Issues Advisory Board from 2014-2017. She led the initiative to adopt the wear of flat shoes by female officers in Service Khakis and Service Dress Blue uniforms. She is also a member of the Parenteral Drug Association, International Society of Pharmaceutical Engineers, and Commissioned Officers Association. In her free time, she enjoys spending time with her family (spouse Ernie and daughters Adele and Maya), jogging, walking their puppy, traveling, and co-leading two Girl Scout troops.
Additional Information
Page Last Modified on 1/25/2023
