Trace Custer

Senior Vice President Quality And Regulatory Affairs at OraSure Technologies

Trace Custer has over 25 years of work experience in quality and regulatory affairs, with expertise in developing and implementing quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement.

Their most recent position was as the Senior Vice President of Quality and Regulatory Affairs at OraSure Technologies, where they were responsible for developing and monitoring company programs to assure product quality and compliance.

Prior to that, they served as the Global Head of QA at Invitae, where they led the evolution of the Quality System programs across their network of clinical testing laboratories and manufacturing plants.

Trace also worked as a Director at Custer Consulting, partnering with clients to find simple solutions to complex problems in areas such as Quality System design, Regulatory Affairs, and Operations Excellence.

Trace Custer held various positions at Thermo Fisher Scientific, GE Healthcare, Labcorp, Genzyme, and Genzyme Genetics, where they contributed to the development and implementation of quality assurance and regulatory compliance programs, as well as strategic planning and process improvement initiatives.

Throughout their career, Trace Custer has demonstrated a commitment to creating a culture of continuous improvement and driving positive change within organizations.

Trace Custer earned a Bachelor of Arts degree in Biology from the University of Iowa from 1985 to 1988. In 2014, they obtained a Regulatory Affairs Certificate specifically in Medical Devices from the Regulatory Affairs Professional Society. Additionally, in the same year, Trace Custer completed an MDC Program in Executive Leadership from Crotonville Alumni.


Previous companies

Sanofi logo
Invitae logo
LabCorp logo
GE Healthcare Systems logo
Thermo Fisher Scientific logo


  • Senior Vice President Quality And Regulatory Affairs

    November, 2022 - present

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