Katarina Bartle
About Katarina Bartle
Katarina Bartle is the Head of Quality at Amylyx Pharmaceuticals, where she has worked since 2020. She has extensive experience in quality assurance and compliance, having held various leadership roles in the pharmaceutical industry, including positions at Karyopharm Therapeutics Inc. and EMD Serono.
Current Role at Amylyx Pharmaceuticals
Katarina Bartle serves as the Head of Quality at Amylyx Pharmaceuticals, a position she has held since 2020. In this role, she is responsible for overseeing quality assurance and compliance efforts within the organization. Bartle plays a strategic role in ensuring that the company maintains its inspection readiness and leads health authority inspections. Her responsibilities include coordinating with stakeholders to apply lessons learned across global development programs, addressing systemic gaps, and developing audit programs to ensure adherence to regulatory requirements.
Previous Experience at Karyopharm Therapeutics Inc.
Before joining Amylyx Pharmaceuticals, Katarina Bartle worked at Karyopharm Therapeutics Inc. in various roles. She served as Senior Director of GMP QA from 2018 to 2020, where she provided strategic direction to maintain the company's good standing with regulatory agencies. Prior to that, she held the position of Director of QA/QC from 2017 to 2018. Additionally, Bartle briefly worked as Senior Director of Commercial Quality in 2020. Her tenure at Karyopharm spanned a total of three years.
Background and Education
Katarina Bartle studied at Bundeswehr University Munich from 1993 to 1997, where she completed her degree. She also pursued further education at the University of Massachusetts Lowell. Her academic background laid the foundation for her extensive career in quality assurance and regulatory compliance within the pharmaceutical industry.
Experience in Quality Assurance
Katarina Bartle has significant experience in quality assurance and compliance, with a career spanning over 15 years. She worked at EMD Serono as a QA Manager from 2005 to 2011, where she managed quality systems in compliance with GxP regulations. Bartle also served as Associate Director of External QA at Shire from 2015 to 2017. Her expertise includes in-depth knowledge of International Conference on Harmonization (ICH) guidelines and extensive experience in managing quality systems across various regulatory frameworks.