In today’s episode I was joined by Maja Pedersen, Chief Technology Officer at Fujifilm Diosynth Biotechnologies.

I really wanted to speak to Maja because she leads quality and IT across six global sites, and has a brilliant perspective on how quality leadership is evolving - especially when it comes to people, systems and technology.

She has a calm, clear way of thinking, and we covered everything from shifting your mindset as a leader, to integrating AI in a global quality function, to maintaining personal resilience and clarity.

We talk about the following:

🎙️ Making the leap from tactical to strategic thinking

🎙️ Leading teams across multiple countries, time zones and cultures

🎙️ Building trust in new teams and showing up authentically

🎙️ Balancing the people side of quality with system thinking

🎙️ How to think and lead when you're not the technical expert

🎙️ Staying grounded and maintaining well-being while leading at scale

🎙️ Where quality and IT need to work hand in hand

🎙️ Why quality leaders must develop digital and data fluency

🎙️ How AI will reshape the future of quality in biotech

🎙️ Advice for future leaders stepping into global roles

Maja is a thoughtful, strategic leader who balances big-picture thinking with deep care for people and culture.

You can watch on LinkedIn Live at 8am EST today or listen via Apple or Spotify.

Thank you Maja for sharing your incredible journey.

Hope everyone enjoys the show!

From engineering student to SVP of Quality - Carolina shares how curiosity, resilience, and mentorship shaped her journey.

In today’s episode I was joined by Carolina Valoyes, Senior Vice President of Quality and Compliance at BioNova Scientific.

I really wanted to speak to Carolina because her story is one of bold decisions, genuine self-awareness, and a leadership style grounded in service, not ego.

She started out as an engineer in Colombia, came to the US without speaking a word of English, and moved her way into biotech leadership by staying curious, staying humble, and always aiming to contribute. Her reflections on mentorship, emotional resilience, and coaching-based leadership were powerful.

🎙️ We talk about the following:

• How she went from Colombia to the US without knowing English and starting her career in Biotech at Bayer
• Her first role supervising a team 15 years her senior
• What an early inspection mistake taught her about resilience
• Her transition from manufacturing into quality
• The guiding principles that drive her career decisions
• Whether curiosity can be taught - and how to coach it
• The importance of painting a positive vision, not using fear
• Advice for navigating “politics” at VP level
• What she looks for when hiring leaders
• Her advice to aspiring quality leaders

Carolina is an inspiring leader who brings humility, sharp thinking, and deep care for people into every part of her work.

Thank you, Carolina, for sharing your incredible journey.

Hope everyone enjoys the show!

In this episode of Let’s Talk Quality, Hemish speaks with Jose Caraballo, a biotech leader with over 30 years of experience in process engineering, manufacturing science, and quality leadership.

Jose started his career in process engineering, optimizing yields and scaling up production.

Over time, he made a deliberate shift into quality leadership, recognizing that understanding the external side of the business - suppliers, regulators, and customers, was just as important as technical expertise.

Now, as a VP of Quality at Kite Pharma, a leader in cell therapy manufacturing, Jose is deeply involved in shaping the future of quality in biotech and remains passionate about driving innovation and leadership in the biotech space.

In this conversation we cover:

✅ The shift from compliance-focused quality to strategic quality leadership

✅ Why quality is a company-wide responsibility, not just a QA function

✅ How moving from technical roles to quality leadership can accelerate career growth

✅ The importance of curiosity and adaptability in biotech

✅ How CGT is changing expectations for speed, risk management, and patient impact

✅ The role of automation and AI in quality systems

✅ Lessons from moving into senior leadership and managing teams effectively

✅ What biotech companies need to focus on to embed quality culture at every level

Jose’s career journey is a great example of how technical expertise, business strategy, and leadership all come together to drive impact in biotech.