🎙️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! 🚀