Stacy Newalu, MPH, RQAP-GCP, CCRC, Vice President, Quality Services, is a clinical research compliance and regulatory subject matter expert with over 20 years of experience. She is a former U.S. Food and Drug Administration (FDA) Regulatory Health Project Manager (RHPM) and Safety RHPM and has held a senior management position for a human subjects protection program/institutional review board (IRB). Prior to joining the FDA, she was the administrative director for an academic outpatient clinical research center. At Advanced Clinical, Stacy leads global regulatory inspections and manages the Quality Services team and projects, providing quality assurance, GxP compliance and inspection readiness services to pharmaceutical and biotechnology companies. Stacy holds a Master of Public Health degree in communicable diseases and Bachelor of Science degrees in both microbiology and medical technology. She is credentialed by the Society of Quality Assurance as a Registered Quality Assurance Professional in Good Clinical Practice.