Markus Gruell MSc Autolus Ltd.

Markus Gruell is Senior Vice President Quality for Autolus, a London-based CAR-T manufacturing company. He joined Autolus in 2019 as Director QA/QP and has overseen the development and design of the PQS infrastructure, the transition from paper to electronic QMS, as well as the implementation of several GxP systems supporting the commercial setup for a CAR-T cell product. As Head of Corporate Quality he is responsible for GMP and GCP Compliance, Supplier Management and GxP Systems, and leading the inspection readiness for GMP and GCP inspections by FDA, EMA and MHRA as part of the commercialisation process for Autolus’ first commercial CAR-T cell product (obe-cel). He has also been responsible for the buildout of Autolus’ own GMP manufacturing site ‘The Nucleus’ from a Quality perspective. Prior to joining Autolus he held various Quality and Manufacturing positions in hospitals, Clinical Reasearch Organisations and pharmaceutical companies. Markus holds a Master’s degree in Pharmacy from Ludwig-Maximilians-University in Munich, Germany, and a second Master of Science in Pharmaceutical Technology and Quality Assurance from University of Leeds, UK. In addition, he completed a Postgraduate Certificate in Clinical Pharmacy at Julius-Maximilians-University in Würzburg, Germany, and a Certificate in Radiopharmacy at King's College, London.