Trace Custer
Business Owner at Custer Consulting - Quality & Regulatory | Santa Fe, New Mexico, United States
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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.
Business Owner at Custer Consulting - Quality & Regulatory in November 2015 to Present
Senior Vice President Quality and Regulatory Affairs at OraSure Technologies in October 2022 to April 2025
Global Head of QA at Invitae in August 2019 to November 2022
Strategy Consultant at Thermo Fisher Scientific in June 2016 to July 2017
Executive Director - Quality and Regulatory Affairs at GE Healthcare in October 2013 to July 2015
Director Quality Systems (Clarient) at GE Healthcare in December 2012 to June 2014
Associate Vice President - Japan Lab Operations / Quality Systems/ Regulatory Affairs at Labcorp in May 2006 to December 2012
Director Quality at Genzyme in May 2000 to May 2006
QA & QC Manager at Genzyme Genetics in May 1994 to May 2000
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Quality Systems
Validation
Compliance
Process Improvement
Six Sigma
Quality System
CAPA
Quality Control
GLP
Quality Assurance
Continuous Improvement
Program Management
Laboratory
Business Process Improvement
Quality Management
ISO
FDA
Change Control
Software Documentation
Biotechnology
Leadership
GMP
Lifesciences
Sop
Laboratory Medicine
LIMS
Oncology
Microbiology
Pharmaceutical Industry
Genetics
Regulatory Affairs
Medical Devices
GCP
Life Sciences
Management
SOP
Corrective and Preventive Action (CAPA)
Good Laboratory Practice (GLP)
Leadership Development
Laboratory Skills
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
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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
Trace Custer Phone Numbers
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