Markus Gruell on building and overseeing the Autolus quality organisation from the very early stages! — Let's Talk Quality

In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK.

Marcus, shares his journey in the industry and his role as VP of Quality at Autolus. We talk about his transition into the cell and gene therapy field and the challenges and opportunities it presents and move into his experience at Autolus, where he started as an associate director and worked his way up to SVP of Quality. Markus discusses the challenges faced by Autolus in their journey from a start-up to a commercial cell therapy company, the impact of COVID-19 and Brexit on their operations, as well a the transition from a paper-based QMS to an electronic QMS (EQMS) and the importance of having flexible systems.

Transitioning into the cell and gene therapy field requires a steep learning curve
The need for having the ability to work in a fast-paced, evolving environment.
The importance of flexibility, adaptability, and collaboration
The transition from a paper-based QMS to an EQMS
The impact of COVID-19 and Brexit posed challenges for Autolus
How patient impact is the driving force for Autolus
How they strive to provide the best safety and efficacy data
Essential qualities for quality leaders

Chapters

00:00: Introduction and Overview
05:04: Getting into Science and Quality Role
09:06: Differences in Quality Practices Between Countries
13:34: Transitioning into the Cell and Gene Therapy Field
19:25: Implementing Quality Systems at Autolus
23:26: Transitioning to an Electronic QMS
26:38: Challenges of COVID-19 and Brexit
30:43: Patient Impact in Cancer Treatment
34:35: Preparing for Pivotal Trials and Commercialization
37:28: Looking Ahead: Excitement for Commercialization
39:14: Values to Live and Die By
41:50: Leaving a Legacy
44:05: Advice for Future Quality Leaders

Thank you Markus for sharing your incredible journey and excited to see you and your teams work come to fruition.

I hope you enjoy the show!

Markus Gruell | LinkedIn