Julie La Rocca,RAC,CHPC,CHC

Julie La Rocca, RAC, CHPC, CHC has extensive experience in the healthcare and life sciences industries. Julie began their career in 1999 as a Research Scientist at Ventana Medical Systems, where they developed detection chemistries for automated IHC assays for in vitro diagnostic (IVD) submissions, performed validation studies for class II IVD devices including instrument software, and participated in design control phases and design reviews. In 2004, they moved to Molecular Profiling Institute as the Director of IHC & Quality Assurance. From 2008 to 2016, they held various roles at Caris Life Sciences, including Senior Director, Quality & Regulatory Affairs, Director, Quality Process Improvement, and Director, R&D Operations. In this role, they led cross-functional process mapping activities to drive quality processes and an effective Quality Management System (QMS), led gap assessments to FDA, ISO 13485, ISO 15189, CLIA, CAP, and New York State (NYS), and maintained state and federal licenses and managed NYS submissions. In 2016, they joined Guardant Health as Senior Director Quality. Currently, they are the VP, Quality Assurance & Regulatory Affairs at Geneoscopy.

Julie La Rocca has an extensive education history. Julie earned a Bachelor's degree in Cell/Cellular and Molecular Biology from the University of Arizona in 1998. In 2001, they went on to obtain a Master's degree in Biochemistry and Molecular Biology from the University of Alaska Fairbanks. In 2012, they earned a Master's degree in Regulatory Affairs from San Diego State University and also completed a Medical Device Certificate Program from the Regulatory Affairs Professional Society. Additionally, they have obtained certifications in RAPS Member (Regulatory Affairs Certification Program) in 2012, Biomedical Research (CITI Program, A Division of BRANY) in 2021, GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) (CITI Program, A Division of BRANY) in 2021, and RAPS Member (Regulatory Affairs Certification Program) in 2012.