Markus Gruell on building and overseeing the Autolus quality organisation from the very early stages!

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 curveThe 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 AutolusHow patient impact is the driving force for AutolusHow they strive to provide the best safety and efficacy dataEssential qualities for quality leadersChapters00:00: Introduction and Overview05:04: Getting into Science and Quality Role09:06: Differences in Quality Practices Between Countries13:34: Transitioning into the Cell and Gene Therapy Field19:25: Implementing Quality Systems at Autolus23:26: Transitioning to an Electronic QMS26:38: Challenges of COVID-19 and Brexit30:43: Patient Impact in Cancer Treatment34:35: Preparing for Pivotal Trials and Commercialization37:28: Looking Ahead: Excitement for Commercialization39:14: Values to Live and Die By41:50: Leaving a Legacy44:05: Advice for Future Quality LeadersThank 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