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 GxP Compliance, Supplier Management and 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/ AUCATZYL). He has also been accountable 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 ia a trained and registered pharmacist and holds a Master’s degree in Pharmacy from Ludwig-Maximilians-University in Munich, Germany. In addition, he completed a second MSc in Pharmaceutical Technology and Quality Assurance from University of Leeds, UK, and an MBA Fundamentals course at Oxford University. He also holds Postgraduate Certificates in Clinical Pharmacy and Radiopharmacy.