BACKGROUND
FOCUS AREAS
EXPERTISE
30 Years of Medical Device and Pharmaceutical Quality and Regulatory Experience
10 Years of Consulting Services Leadership and Delivery Experience.
Quality Strategy
ISO / FDA / MDD/ CMDCAS QSR
GMP and GLP
CFDA
JPAL and GCP Quality System
Maintenance and Compliance Globally
Corporate Warning Letter Remediation
Quality Metrics and Quality Culture
Experience in global systems turnarounds, acquisitions, domestic and international regulatory requirements, and implementing large scale restructuring efforts and integrations.
As President of Eliquent Remediation Solutions, Brian leads a team of ex-industry expert partners in engaging with clients across Medical Device, Pharmaceutical, Diagnostics, and Biotech to help them respond to regulatory and enforcement challenges from various global regulators.
Brian brought more than 30 years of Regulatory, Quality, and Operations industry experience in Medical Device and Pharmaceuticals to Eliquent when he joined the organization in 2016. This included extensive experience in building relationships with global regulatory agencies across a wide range of product portfolios and operational locations along with successfully navigating minor and major enforcement actions as the leader of Quality and Regulatory for several multinational corporations.
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EDUCATION:
University of Arkansas
Bachelors of Science degree in Chemical Engineering. -
AREAS OF EXPERTISE:
Brian Burns is President and a quality leader at Validant (now ELIQUENT Life Sciences, Inc.), based in the New England region. Mr. Burns brings deep executive experience in Quality and Regulatory strategy and improvement with a track record of comprehensive quality performance improvement.
Prior to joining ELIQUENT, he served as an Executive Vice President of Global Quality and Regulatory Affairs at Haemonetics Corporation and Fresenius Medical Care over the course of five years. Mr. Burns led institutionalizing corporate quality systems for all operational areas and upgraded quality systems to support evolving business needs such as combination products, while improving complaint handling, operational metrics, supplier quality, clinical quality, and global quality systems training.
Mr. Burns served as Executive Vice President of Global Quality, Medical Safety & Regulatory Affairs of Boston Scientific Corporation for seven years. Mr. Burns was responsible for quality assurance for Boston Scientific’s businesses worldwide and served as company liaison to all compliance bodies, including the U.S. Food and Drug Administration, European Union Competent Authorities and the Ministry of Health, Labour and Welfare, Japan.
Previously, Mr. Burns held various Quality Assurance, Operational and General Manager roles with Cardinal Healthcare, Allegiance Healthcare, and Baxter Healthcare. He received his Bachelor of Science degree in Chemical Engineering with a Minor in Mathematics and Chemistry from the University of Arkansas.
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