🎙️Would you move to a new country with no network, no guarantees - just a dream and two suitcases?

That’s exactly what Katarina Bartle did.

She left Slovakia, where she had built a strong academic foundation, moved to Germany for her PhD, and then took a huge risk, relocating to the U.S. for what was meant to be a short postdoc.

27 years later, she’s still here - now a biotech quality leader who has shaped global teams and helped redefine how companies approach quality.

In today’s episode of Let’s Talk Quality, Katarina shares:

✅ The challenges of moving to a new country and building a career from scratch

✅ How she transitioned from scientist to compliance and quality leader

✅ The importance of having a strong voice in leadership discussions

✅ Why quality leaders need to think like business leaders, not just auditors

✅ Her biggest leadership lessons and career advice for aspiring VPs

This one is packed with career insights, resilience, and real leadership lessons—don’t miss it.

In today’s episode, I was joined by Biana Torres, Senior Director of Quality Assurance at Encoded Therapeutics.

I really wanted to speak to Biana because she has built a strong leadership career in quality, moving through both big pharma and small biotech. She’s now leading in the dynamic world of cell and gene therapy, where quality and adaptability are critical.

Biana started out aiming to be a doctor, pivoted into biotech by accident, and has since built a career leading quality teams through acquisitions, evolving regulations, and high-impact projects that put patients first.

We talk about the following:

🎙️ Her unexpected entry into quality through a temp job at Baxter

🎙️ The transition from big pharma to small biotech and what she learned from both

🎙️ Why cell & gene therapy is different from traditional small molecule and biologics

🎙️ How quality leadership has evolved from being "the police" to a business partner

🎙️ The impact of working at Kite during a pivotal time for the industry

🎙️ How she overcame the "no CGT experience, no interview" hiring barrier

🎙️ The mindset shift needed to work in advanced therapies

🎙️ The importance of coaching & mentorship in leadership development

🎙️ Why future quality leaders need to think outside the box

Biana is a passionate leader who thrives in fast-moving biotech environments. She’s driven by curiosity, continuous learning, and a commitment to mentoring the next generation of quality leaders.

Thank you, Biana, for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode, I was joined by Shane Ernst, Vice President of Quality at Empower Pharmacy.

I really wanted to speak to Shane because he has built an incredible career in quality leadership despite being an introvert - a trait many in the industry can relate to. His journey from analytical chemist to VP is full of valuable insights on leadership, career progression, and navigating high-stakes regulatory challenges.

We talk about the following:

🔹 How he accidentally fell into quality after starting in analytical chemistry

🔹 The early career moment that forced him to step up despite his introverted nature

🔹 Why quality leaders need to develop cross-functional business knowledge

🔹 His biggest leadership challenge - building confidence as an introvert

🔹 How he learned to manage his energy as a leader while staying authentic

🔹 What it was like turning around a 1,300+ complaint backlog at a major pharma site

🔹 Why trust with regulators is essential and how to build it

🔹 The shift from tactical to strategic thinking when moving from Director to VP

🔹 How he develops and mentors future leaders in quality

🔹 His advice for aspiring VPs - getting out of your comfort zone is key

Shane is a fantastic example of how leadership isn’t about personality type - it’s about mindset, adaptability, and growth. His story proves that introverts can thrive in senior leadership roles and have a huge impact on their teams and companies.

Thank you, Shane, for sharing your incredible journey.

Hope everyone enjoys the show! 🚀 

In this episode of Let’s Talk Quality, Hemish sat down with Rob Dallimore, Head of Quality at Wugen, to discuss his inspiring 25+ year journey in quality assurance and leadership. Rob’s experience spans small molecules, biologics, and cell therapy, giving him unique insights into what it takes to succeed across different modalities.

Rob shared invaluable lessons from his career, including the mindset required to pivot into new areas of expertise, how to build resilient teams, and his experience leading quality systems for commercialization at both start-ups and Big Pharma.

Key highlights include:

🎤 Rob’s transition from the UK to the US and stepping into leadership roles.

🎤 The challenges of job hunting in a highly competitive biotech industry.

🎤 Navigating the shift from small molecules to biologics and cell therapy.

🎤 How to hire and train QA teams without specific modality experience.

🎤 The importance of leading with empathy, resilience, and adaptability.

🎤 Building compliant, efficient quality systems for commercial readiness.

🎤 Lessons learned from late-stage clinical trial failures and bouncing back stronger.

🎤 Wugen’s mission to license the first allogeneic CAR-T therapy in the US.

Rob’s career demonstrates the power of stepping outside your comfort zone and taking on challenges to drive meaningful impact in the life sciences industry. 

Thank you, Rob, for such an insightful conversation. We’re looking forward to seeing Wugen’s exciting journey unfold.

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!