Let's Talk Quality

In today's episode, I'm joined by Jon Voss, one of the all-time quality greats!

I've been working with Jon over the past 18 months. I'd describe him as a true gent - very humble, incredibly funny with a dry sense of humour, and someone who is so passionate about this industry.

Unsurprisingly he has developed some of the leaders I've interviewed on this show!

What shines through in this episode is the balance between pragmatism and patient safety.

We talk about the following:

• The evolution of quality from compliance-driven to patient-first approaches
• Why and how moving around different careers benefited Jon's career.
• Lessons learned from leading quality teams through commercialization milestones.
• Phase appropriate quality and how to actually implement systems accordingly.
• Keeping the end goal in mind whilst maintaining patient safety.
• Utilising Technology and AI to speed up drug development
• How to transition into commercial quality.
• Why learning how to speak in public will improve your career opportunities.

Jon is so passionate about helping and inspiring the next generation of leaders. His stories and advice offer invaluable insights for anyone working in or aspiring to quality leadership roles.

Thank you, Jon, for sharing your incredible journey, wisdom and lessons you've learnt.

Whatever level you are in your career, there is something to be learned from in this episode.

Hope everyone enjoys the show!

On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Hanh Nguyen, Site Head of Quality at Minaris Regenerative Medicine, a global CDMO specializing in cell and gene therapies.

Hanh’s career started in document control at Amgen, spending over a decade in Big Pharma, before taking a leap into smaller, fast-paced organizations. That move - stepping out of her comfort zone, was a pivotal moment that accelerated her growth and confidence as a leader.

Hanh is a brilliant example of someone who’s balancing rapid career progression with deep self-awareness. In this episode, she opens up about:

✅ Overcoming imposter syndrome and trusting your experience.

✅ How to adapt your leadership style to motivate and engage a new generation of talent.

✅ The importance of prioritizing mental health - both for yourself and your team.

✅ Creating strong relationships between sponsors and CDMOs to drive success.

If you’re a quality leader (or aspiring to be one), this episode is packed with practical tips and insights on building high-performing, engaged teams while staying true to yourself.

Hope you enjoy the show!

On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Sang Yoon, VP of Quality Assurance at ImmunityBio, a cell and gene therapy company based in California.

Sang’s story is truly inspiring. With 25+ years in biologics, medical devices, and healthcare, he’s been at the forefront of product launches, recalls, and scaling operations globally. But what stood out to me most was his approach to leadership:

✅ Build a community first

✅ Lead with trust, self-awareness, and adding value

✅ Create a culture where people thrive, learn, and grow

Sang shared so many practical tips for quality leaders, especially around shaping culture in the first 90 days of a role and developing your leadership style:

1. Build relationships across all levels of the team
2. Be self-aware: your actions and words influence culture
3. Focus on developing learning organizations
4. Add value to your people—find ways to help them thrive

We also talked about Sang’s experiences transitioning from sponsor companies to CDMOs and what really excites him about ImmunityBio’s journey.

If you’re an aspiring leader, there’s so much to take from this conversation. Thank you, Sang, for sharing your insights! 🎙️

On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Swetha Krishnan, Executive Director and Head of Quality at Mural Oncology, a fast growing biotech in Waltham, Massachusetts.

Here's what they discuss:

• How Swetha's upbringing shaped her career progression 🚀
• Moving from India to the US to pursue a career in science 🧬
• Why wearing so many hats early on improved her confidence 👏
• Why you don't always need all of the answers 🗯️
• Balancing technical expertise with emotional intelligence ✴️
• Learning to be adaptable and removing biases ✔️
• How to develop and build credibility as a leader🔥

If you’re an aspiring leader, this episode will help you understand some of the key traits and characteristics to focus on to reach your full potential as a people leader.

Huge thank you to Swetha for joining us on the show!

In this episode, I had the privilege of speaking with Matthew Wheeler, Vice President of Quality and Clinical Operations at Precision BioSciences.

Matthew’s journey is nothing short of inspiring. From starting his career in food manufacturing at Kellogg's to building a career in biotech, his story is one of resilience, adaptability, and leadership.

In the past year, Matt was diagnosed with not one, but three rare diseases, including GPA vasculitis and IgA nephropathy.

Despite these challenges, he continues to lead with strength, empathy, and gratitude.

We covered a lot of ground in this conversation, including:

• Transitioning from food manufacturing into biotech and navigating the early challenges of his career.
• The breadth of experience gained that shaped his expertise.
• The importance of mentors and leadership in personal and professional growth.
• Building a quality function at Precision BioSciences and integrating quality into R&D operations.
• His personal health challenges and how they've influenced his outlook on life and leadership.
• His commitment to service, gratitude, and family as guiding principles in his life.

Matthew’s candidness about his recent health challenges and their impact on his perspective was incredibly moving.

Thank you, Matt, for sharing your story with such honesty and vulnerability. It’s leaders like you who remind us of the impact that Life Science professionals have on patients’ lives.

I hope you enjoy hearing Matt’s story as much as I did—it’s one you won’t forget!

In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences, and the importance of connecting work to patient outcomes. She emphasizes the challenges and rewards of working in quality assurance, the significance of practical quality, and the need for purpose-driven leadership. Lauren also highlights the importance of employee development, self-awareness, and the impact of pivotal moments in her career.

Takeaways:

• Lauren fell into quality assurance rather than choosing it intentionally.
• Her early experiences in environmental monitoring were invaluable for her career.
• Quality roles allow for direct impact on patient safety and product quality.
• The quality assurance field is constantly evolving and challenging.
• Lauren values authenticity, integrity, and kindness in her leadership.
• She emphasizes the importance of connecting work to a greater purpose.
• Practical quality and team dynamics are crucial for success in quality assurance.
• Employee development should be tailored to individual goals and needs.
• Self-awareness is key to effective leadership and personal growth.

Lauren believes in leaving a quiet legacy through her interactions with others.

For anyone looking to learn about how to hire great people, build a purpose driven culture, and develop their people, this is a great episode to listen to!

Thank you Lauren for joining us!

Hope everyone enjoys the show!

Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and opportunities that come with it.

He emphasizes the importance of being willing to challenge the status quo, having an openness to learning, and practicing empathy as a quality leader.

Smith also discusses the need for quality to be seen as an asset and the importance of building empowered and diverse teams. He encourages aspiring quality leaders to become experts in one or two areas to differentiate themselves.

Takeaways:

• Be willing to challenge the status quo and ask why things are done a certain way.
• Have an openness to learning and constantly strive to improve.
• Practice empathy and build relationships to create a positive quality culture.
• View quality as an asset and strive to integrate it early in the product realization process.
• Differentiate yourself as a quality leader by becoming an expert in one or two areas.

In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech.

Andrea shares her career journey and insights into quality leadership. She 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!

In today's episode, we're joined by Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics.

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. We talk about the benefits of gaining exposure to different areas of an organization and how that has helped Gary become the leader he is today!

We discuss 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!

In today's episode I was 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! I wanted to talk with Andrew to learn about his journey and how he's gone developing himself - both as a quality professional and 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

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 to 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.

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.