Dr. Nadja Huetz Joins BioAgilytix as Director of Quality Assurance

Dr. Huetz Brings 12 Years of Quality Assurance (QA) Experience in GCP, GLP, and GMP Environments to Guide QA Operations at BioAgilytix’s European Headquarters in Germany

NOVEMBER 1, 2017—Hamburg, Germany—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has announced the addition of Dr. Nadja Huetz to its Quality Assurance (QA) team at their European headquarters in Hamburg, Germany. As Director of Quality Assurance, Dr. Huetz will be involved in providing comprehensive QA management and support for all European operations in accordance with the company’s Quality Management System (QMS). She will play an integral role in ensuring compliance to appropriate standard operating procedures (SOPs), methods, protocols, plans, and regulatory requirements, as well as providing regulatory input and QMS oversight.

Dr. Huetz has a scientific degree in molecular biology and expertise working with biologics, including biosimilars, in GCP, GLP, and GMP environments through all clinical trial phases. She brings extensive experience from her past QA roles at Sandoz GmbH, most recently as Global Head of Clinical Quality Assurance & Qualified Person (QP), where she was responsible for executing the organization’s global Clinical Quality Management Plan, acting as the responsible QP for Investigational Medicinal Product, and ensuring local Clinical Quality Management Plans were implemented and followed appropriately across Sandoz Clinical Development Centers. Just prior to joining BioAgilytix, Dr. Huetz spent time in the academic world as the Managing Director of the Vienna Clinical Trial Center at the Medical University of Vienna, where she provided leadership, direction, guidance, and management for clinical trial execution of clinical studies within designated clinical trial programs. In this role, she managed authority inspections and led interactions with regulatory authorities and sponsors.

“Quality is an extremely important aspect of our work to deliver robust, reliable, and reproducible bioanalytical results that meet regulatory standards,” said Dr. Arno Kromminga, BioAgilytix’s European Chief Scientific Officer. “Nadja brings a volume of diverse quality expertise to our QA group, with extensive and broad knowledge of EU and EMA requirements and ICH guidelines and firsthand experience interfacing with regulatory authorities. I am confident that she will help us to continue to uphold the very highest quality in our operations to efficiently progress our customers’ innovative studies.”

“I am excited for the opportunity to work with a best-in-class laboratory for large molecule bioanalysis, and look forward to applying my knowledge to help them continue to uphold their strong QA track record,” said Dr. Huetz. “It is great to be part of an organization that places such strong emphasis on quality in everything they do, and I’m looking forward to the chance to develop and implement QA procedures and policies that will further benefit the overall company.”

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About BioAgilytix

BioAgilytix is a leading global bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, and GCP, as well as product release testing under GMP..

BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.

Media Contact:
Carla Nieser
Vovéo Marketing Group
610.240.0400, x 118
c.nieser@voveo.com

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