Trace Custer

About Trace Custer

Dedicated to bringing value, no matter the industry or complexity of the regulatory environments. Committed to developing effective regulatory & quality strategy and implementing systems to enable us to execute our business goals. A curious and collaborative team member, who parters across the business to bring value in both start-up and large, complex organizations. A passionate coach and mentor, developing extraordinary professionals and effective teams - who drive value by not only WHAT, but HOW.

Experience

1. Senior Vice President Quality and Regulatory Affairs

   OraSure Technologies, Inc.

   Nov 2022 — Present · Bethlehem, PA, US

   Responsible for the development, implementation, coordination and monitoring of company programs to assure product quality and compliance with applicable regulatory requirements, guidelines and standards. Partnering across the business to ensure business and manufacturing processes meet customer expectations and regulatory requirements by executing on a clear regulatory and quality strategy, linked to the company business strategy and goals. Developing a continuous improvement culture with the methods of Lean / Six Sigma, coupled with the interpersonal skills needed for high performing teams.

Education

• Regulatory Affairs Professional Society (RAPS)

  Regulatory Affairs Certificate - Medical Devices, Regulatory Affairs - Medical Devices, N/A

  2014 — 2014

• GE Crotonville

  MDC Program, Executive Leadership

  2014 — 2014

• University of Iowa

  BA Biology, Biology

  1985 — 1988