Trace Custer Email & Phone Number

Trace Custer

Business Owner at Custer Consulting - Quality & Regulatory | Santa Fe, New Mexico, United States

Trace Custer Socials
About Trace Custer

Trace Custer serves as the Senior Vice President of Quality and Regulatory Affairs at OraSure Technologies, where he plays a pivotal role in ensuring that the company’s innovative diagnostic solutions meet the highest standards of quality and compliance. With a robust background in clinical laboratory diagnostics, in vitro diagnostics (IVD), and medical devices, Trace is dedicated to navigating the complexities of regulatory environments to deliver exceptional value to stakeholders. His expertise encompasses a wide range of critical areas, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and the implementation of effective Standard Operating Procedures (SOPs).

In his current role, Trace is responsible for the development and execution of comprehensive regulatory and quality strategies that align with OraSure's business objectives. He leads initiatives to establish and monitor programs that ensure product quality and compliance with applicable regulatory requirements, guidelines, and standards. By fostering a collaborative environment, he partners across various departments to enhance manufacturing processes and ensure they meet customer expectations while adhering to stringent regulatory frameworks.

Trace's commitment to continuous improvement is evident in his proactive approach to Corrective and Preventive Action (CAPA) systems and validation processes. His leadership style emphasizes curiosity and collaboration, enabling his team to tackle challenges creatively and effectively. As a key driver of quality assurance and regulatory compliance, Trace Custer is instrumental in positioning OraSure Technologies as a leader in the life sciences industry, ultimately contributing to the advancement of healthcare solutions that improve patient outcomes.

Trace Custer Work
1 experience icon

Business Owner at Custer Consulting - Quality & Regulatory in November 2015 to Present

2 experience icon

Senior Vice President Quality and Regulatory Affairs at OraSure Technologies in October 2022 to April 2025

3 experience icon

Global Head of QA at Invitae in August 2019 to November 2022

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Trace Custer Skills

Quality Systems

Validation

Compliance

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Frequently Asked Questions about Trace Custer

What is Trace Custer email address?

Email Trace Custer at [email protected] and [email protected]. This email is the most updated Trace Custer email found in 2026.

How to contact Trace Custer?

To contact Trace Custer send an email to [email protected] or [email protected]. (updated on October 24, 2024)

What company does Trace Custer work for?

Trace Custer works for Custer Consulting - Quality & Regulatory

What is Trace Custer's role at Custer Consulting - Quality & Regulatory?

Trace Custer is Business Owner

What is Trace Custer's Phone Number?

Trace Custer's phone (505) ***-*114

What industry does Trace Custer work in?

Trace Custer works in the Medical Equipment Manufacturing industry.

Trace Custer Email Addresses

Email Trace Custer at [email protected] and [email protected]. This email is the most updated Trace Custer email found in 2026.

Trace Custer Phone Numbers

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