Senior Vice President Quality & Regulatory
Trace Custer has joined OraSure as Senior Vice President, Quality and Regulatory. In this role, she oversees all Quality and Regulatory activities for our business globally while partnering enterprise-wide to enable customer, employee, and business success. Her experience spans almost 30 years of operations, quality and regulatory affairs across multiple industries and geographies. She has partnered with business leaders and cross functional teams to achieve successful product registrations and implement effective quality systems and manufacturing excellence. Prior to joining OraSure, Ms. Custer served as Global Head of Quality and Regulatory Affairs at Invitae, Associate Vice President (AVP) of Lab Operations and AVP of Quality & Regulatory Compliance at LabCorp, and Executive Director of BioProcess QA at GE Healthcare. She has also partnered with many companies as a consultant to help them take that “next step” in their quality journey. Ms. Custer has a passion for tools such as Lean and Six Sigma which enable Quality and Regulatory to not only ensure compliance, but to help organizations build in quality from the start, simplify processes and reduce waste. She holds a bachelor’s degree in biology from University of Iowa.