A specialized service provider
QA Biotech Consultancy
About Us
QA Biotech Consultancy was founded in 2016 by Dr. Huetz, a seasoned Quality Assurance Specialist and Qualified Person (QP) under Germany’s AMG §15 (3) and (3a), certified in ATMPs, vaccines and pharmaceutical products. With over 20 years of experience in the pharmaceutical and biotechnology industries, Dr. Huetz combines deep scientific expertise with strategic leadership. She holds a PhD in Molecular Biology and Biochemistry from the University Innsbruck, Austria and an MBA from the Wirtschaftsuniversität Vienna, Austria with a focus on Project and Process Management.
Throughout her career, Dr. Huetz has successfully led cross-functional and matrix teams, managed complex clinical and GMP projects and served as a project manager under §15 GenTSV of the Gene Technology Act. Her hands-on experience spans the full quality and regulatory spectrum, including Quality Assurance, Quality Control, Regulatory Compliance, Auditing, Clinical Trials, Project Management and Third-party oversight.
During her 10-year tenure at Sandoz/Novartis — including her role as Head of Global Clinical Quality Assurance — Dr. Huetz led major global initiatives to harmonize Clinical QA procedures across international affiliates. She designed and implemented scalable quality frameworks, streamlined compliance processes and fostered a culture of continuous improvement, significantly enhancing audit readiness and operational consistency across complex regulatory environments.
In addition to her consultancy work, Dr. Huetz served as Managing Director of the Vienna Clinical Trial Center in the Department of Ophthalmology at the Medical University of Vienna, where she applied her expertise at the intersection of clinical research and regulatory excellence.
At QA Biotech Consultancy, Dr. Huetz leverages this extensive experience to support life sciences clients worldwide. The consultancy provides expert guidance in GCP, GLP and GMP compliance—helping organizations build and maintain robust, future-ready quality systems that drive innovation while ensuring regulatory alignment and patient safety.