Perseverance, perspective and people-first leadership in a global quality role.

In today's episode I was joined by Burak Begen, Head of Global Manufacturing Quality at Siemens Healthineers.

I really wanted to speak to Burak because he’s built his career across multiple countries, cultures and challenges, and now leads quality across global manufacturing sites. His journey gives a very real view of what it actually takes to operate at that level.

Burak’s career hasn’t been linear or easy. From starting his career in Turkey, moving to the US for his PhD, rebuilding his career from scratch, and navigating setbacks like job losses and site closures - his story is defined by perseverance and resilience.

What stood out is how those experiences shaped the way he leads today. He leads from the front, sets high standards, but always stays close to his teams. Whether it’s staying late to close records or travelling globally to connect with people on site, his leadership is grounded in accountability and support.

We talk about the following:

• Why perseverance is a defining trait for quality leaders
• Leading global teams across time zones and cultures
• Building a partnership mindset in quality instead of a “policing” approach
• Creating the right KPI culture and avoiding “watermelon metrics”
• Empowering teams to make decisions and building psychological safety

If you are a quality professional managing multiple sites a leader struggling with KPIs, culture or engagement across sites, or someone who wants to step into a larger global role, then this episode is for you.

Thank you Burak for sharing your incredible journey.

Hope everyone enjoys the show.

Great quality leaders don’t just build systems - they build people, culture and confidence.

In today's episode I was joined by Melodie Bryce, Chief Quality Officer at Kincell Bio.

Melodie’s journey is a brilliant example of how diverse experience across manufacturing, supply chain, training and quality can shape a well-rounded quality leader

What stood out most is her approach to leadership. Melodie focuses heavily on building strong teams, developing future leaders and creating an environment where people are supported but also expected to take ownership. She combines high standards with a genuine commitment to coaching and mentorship.

We talk about the following:

· How to assess a quality organisation when you first join

· Why hiring “stronger than you” is critical to building high-performing teams

· What makes a great quality leader in fast-growing biotech environments

· The importance of being a self-starter in quality roles

· How to develop future leaders through coaching and mentorship

· What to look for in the first two weeks of hiring someone

· Leading through remediation and why it accelerates growth

· Building a quality culture where everyone takes ownership

· Balancing compliance with real-world decision making in cell therapy

· Why “digging deep” is the foundation of leadership success

Melodie is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.

If you are a quality leader looking to develop stronger teams and future leaders, then this episode is for you.

Thank you Melodie for sharing your incredible journey.

Hope everyone enjoys the show.

If you are the first quality hire in a startup, your job is not to build everything at once.

Your job is to build the right things first.

That was one of the clearest takeaways from my conversation with Rex Ready on Let’s Talk Quality.

A few practical points he shared stood out:

· Follow the path of the product

· Understand the patient experience

· Focus first on what directly affects patient safety

· Build procedures around processes that already work

· Prioritise quality investment based on stage, modality, and risk

In early-phase environments, it is easy to create a long list of things you would like to have.

An EQMS.

A fuller audit programme.

More formal vendor oversight.

A bigger team.

All of that matters.

But not all of it matters equally on day one.

Strong quality leadership is about judgment. It is about knowing what must be in place now, what can come next, and how to build trust while you do it.

That is especially true in cell and gene therapy, where complexity is high and patient impact is immediate.

A very strong conversation with Rex, and a useful one for anyone building quality in a lean biotech environment.