Let's Talk Quality: The Podcast???

S2 EP16 - Jon Voss on making practical decisions that put patients first. In this episode, Jon shares his wealth of knowledge and experiences, diving into topics that are as inspiring as they are practical: ?? The shift from compliance-driven quality to patient-first approaches. ?? The career benefits of moving across different roles. ?? Lessons from leading teams through commercialization milestones. ?? Implementing phase-appropriate quality systems effectively. ?? Balancing innovation with patient safety. ?? Leveraging technology and AI to accelerate drug development. ?? Tips for transitioning into commercial quality. ?? Why public speaking can transform your career opportunities. Jon’s passion for mentoring the next generation of quality leaders shines through in every story and piece of advice he shares. Whether you’re just starting out or are already a leader, this episode has something for everyone. https://lnkd.in/eYKsHgFi

??? Listen to our final episode of 2024! ??

?? Season 2 | Ep 13 - Swetha Krishnan on going from Individual Contributor to Inspiring People Leader. Out now! ?? Link in the comments ??

Season 2 | Ep 9 - Andrea Goddard on her journey from 'the graveyard shift' to Chief Quality Officer at Genentech. In this weeks episode, Hemish Ilangaratne is joined by Andrea Goddard, former Chief Quality Officer at Genentech. Andrea started in biotech manufacturing and transitioned into quality after a conversation with her boss! Andrea emphasizes the importance of building strong relationships between quality and other departments within an organization. She discusses the challenges and rewards of working in a global role, including managing different time zones and cultures. We cover: ??Building strong relationships between quality and other departments. ??Managing different time zones and cultures. ??The importance of respect, authenticity, and work ethic. ??Using data to make informed choices. ??Putting yourself outside of your comfort zone. A huge thank you to Andrea for joining us on the show and for giving us her time. She's had an incredible 30-year career with Genentech/Roche, starting in 1995, and positively impacting so many lives along the way. Hope you enjoy the show!?? Out now on YouTube and all major podcast platforms. ??

Season 2 | Ep 8 - Gary Barrera on why quality leaders should "walk a mile in their partner's shoes" In today's episode, Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics, Inc. joins Hemish Ilangaratne to talk about his journey in quality! ?? Gary shares that his love for reading and learning, as well as his curiosity about how things work, led him to pursue a career in science. He started in manufacturing and eventually moved into quality, where he discovered his passion for ensuring the reliability and safety of products. He talks about the benefits of gaining exposure to different areas of an organization and how that has helped him become the leader he is today. ?? Listen to learn about the following: ?? The evolution of quality in the industry. ?? The importance of a strong quality culture . ?? The advancements in data integrity. ?? Addressing fraud in the industry. ?? Importance of crisis management. ?? Learning what & how your operational partners do. ?? Collaborating effectively. Chapters 00:00 Introduction and Podcast Inspiration 02:56 Getting into Science and Transitioning into Quality 07:12 The Role of Change Control in Gary's Quality Journey 09:34 The Importance of Quality Culture and Data Integrity 24:37 Pivotal Moments in Gary's Career Journey 35:40 Important Values and Advice for Future Quality Leaders A huge thank you to Gary for joining us! Hope you enjoy the show!??

Season 2 | Ep 7 - Andrew Cieri on adapting to change and creating a vision. ? In today's episode we are joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit. Regeneron are launching a new cell therapy unit after the acquisition of the pipeline and commercialisation rights to 2seventy products and Andrew has been tasked with launching this unit! Throughout his career, Andrew has been proactive, from transitioning into quality from manufacturing, to going back to school to do a Masters in Engineering Management and develop his leadership skills. He's shown self-awareness throughout his career and still to this day is always looking to improve himself as a leader. Chapters 00:00 Introduction and Background 03:58 Early Interest in Science and Technology 07:56 Transition from Manufacturing to Quality 11:14 Transition into Leadership in Quality 22:58 Impact on Product Quality and Reflections 28:03 Current Focus and Future Plans 34:12 Values for Success in Quality Assurance 36:39 Leaving a Legacy and Advice for Future Leaders 39:23 Conclusion and Contact Information Thank you for joining us, Andrew, and looking forward to seeing all the amazing work you and your team do for patients in the future. Episode out now! ??

Season 2 | Ep 6 - Laura Malagon on going from washing glassware in laboratories to VP Quality! ? In today's episode Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing joins Hemish Ilangaratne to talk about her career journey. ? Laura recently relocated from Miami to Michigan to lead the quality and regulatory functions at GRAM. She's had a fantastic journey in quality, starting her career washing glass-wear in a laboratory! They discuss the following: ? ?? Relocating from Miami to Michigan this year for a new VP role. ?? Laurie's journey into science and quality. ?? Working with different modalities, therapeutics and organizations. ?? Laurie's love for quality and why she still has a passion for the industry. ?? How the industry has evolved since she started. ?? Communicating and leading cross-functionally. ?? Moving from established organization to start-up. ?? Laurie's hope for the future ?? Advice for quality professionals ?? The one person who inspired her the most. ? Laurie is kind, generous and incredibly passionate about leadership, quality and bringing safer medicines to patients. She's shown resilience throughout her career which has allowed her to widen her remit and grow her career. Her ambition to further her career shines throughout this conversation. ? Thank you Laurie for sharing your incredible journey from washing glass-wear all of those years ago to where you are now!?? ? Episode out now on all major podcast platforms.??

Season 2 | Ep 5 - James Myers on becoming a true GxP quality leader. ? Hemish Ilangaratne is joined by James Myers, VP Quality at Spyre Therapeutics. ? James discusses his journey from GCP focussed roles into GMP, and as a result, gaining exposure across all aspects of compliance. They talk about this transition and what it takes to become a true GxP quality professional, and more! ? ?? Transitioning from GCP to GMP. ?? What it takes to move from director to VP.? ?? Building a Team and Pilot Plant.? ?? Collaboration with Stakeholders. ?? Gaining Organizational Buy-In. ?? Importance of Listening. ?? Strategic Thinking. ?? You can listen via Apple or Spotify by searching Let's Talk Quality! ?? ? Thank you James for joining us and sharing your journey! ?? ? Hope everyone enjoys the show! Episode links below??

Season 2 | Ep 4 - Kelly O'Hare on defining and articulating the value of quality to your organisation.?? Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a non-viral gene therapy focussed on the treatment of bladder cancer, joins Hemish Ilangaratne on todays episode! ? Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being able to articulate the value of quality to their organizations. Her insights provide valuable lessons for aspiring quality professionals and leaders. ? Chapters ??00:00 Introduction to Quality and Career Journey. ??02:55 Transitioning from Science to Quality Leadership. ??06:03 Building Confidence in Quality Decisions. ??08:52 Defining and Articulating Quality. ??11:59 The Importance of Quality Management Systems. ??14:58 User Feedback and Quality System Implementation. ??17:59 Evolving Perceptions of Quality in Organizations. ??20:55 Inspiring Passion for Quality in Teams. ??23:50 Legacy and Mentorship in Quality Leadership. ??27:02 Final Thoughts and Advice for Future Leaders. ? This is a great conversation about why and how to define and articulate quality and the benefits this can bring to your career, your organisation, and the patient populations you serve. ? A huge thank you to Kelly for joining us on the show and sharing her journey. Episode available now on Apple and Spotify? We hope you enjoy the show!??

??Season 2 | Ep 3 - Markus Gruell on building and overseeing Autolus Therapeutics quality organisation from the very early stages! In today's episode Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK joins us to share his journey in quality. Marcus discusses 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. He talks about 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 and the importance of having flexible systems. 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, we hope you enjoy the show! ? Episode available now on Apple and Spotify!