What does it really take to build a quality organization from the ground up - and do it again, and again, across multiple companies? Laura Singer on building quality that scales.

In today's episode I was joined by Laura Singer, Vice President of Quality and Compliance at Loyal. I really wanted to speak to Laura because she has spent the better part of two decades walking into an early-stage biotech and building everything from scratch. Each time, a different product, a different regulatory landscape, a different team. And each time, the same fundamental challenge: how do you build quality infrastructure that is fit for today, but will not break tomorrow?

Laura's career is a study in what it means to grow as a quality leader. She started in quality systems, realized she wanted more breadth, and made a deliberate move into a full GXP leadership role at Amicus as VP of Quality - a company that was developing its first commercial product for a rare disease. She came in as a senior director, proved herself, and earned the VP title. From there she spent six years at Heron Therapeutics building out an international quality function, and has since continued that pattern in successive roles.

What makes Laura a compelling guest is not just the technical expertise - it is her philosophy. She talks about quality not as a compliance function, but as a business partner. She talks about leadership not as direction-giving, but as creating the conditions for other people to own their work. And she talks about the job of a quality head at the executive level with unusual clarity: you walk in with a plan, you are calm, you translate the regulations for the people around you, and you do not retreat when things go wrong.

We talk about the following:

• What it means to find your niche as a quality leader and how Laura discovered hers

• Making the leap from a specialist quality systems role to a full GxP VP position without a network inside the company

• How to communicate with a C-suite and executive team as a quality leader - and where most people get it wrong

• What actually breaks in a quality system when a company scales from 40 to 140 people

• How to define inspection readiness in practice, including the CDMO piece that often gets underestimated

• Leadership philosophy, hiring for fit, and the importance of executive presence in quality

Laura 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

professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.

Thank you Laura for sharing your incredible journey. Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR

• Quality leaders at VP and SVP level who are navigating the transition from compliance-focused to business-aligned quality leadership

• Heads of Quality at early-stage biotechs who are building or scaling their quality function for the first time

• Senior Directors and Directors of Quality who are ready to make the step up to VP and want to understand what that leap really looks like

• Quality professionals at any level who want to build stronger relationships with their C-suite and executive team

• Anyone in the life sciences who wants to understand what good quality leadership actually looks like in practice

From the lab bench to the C-Suite - and every crisis in between.

In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics.

I really wanted to speak to Kim because her career trajectory is unlike almost anyone else I have interviewed on this show. She is a PhD virologist who began her career in the QC lab at Biogen, and over the following two decades built herself into one of the most accomplished quality and technical operations executives in the industry. She has led through warning letters, product recalls, complete response letters, workforce reductions, and commercial drug launches - often all at the same organisation. Her story is one of relentless curiosity, self-belief, and a genuine commitment to the patient at every stage.

Kim talks about the pivotal moment early in her Biogen career when she was pulled out of the lab to help lead the effort to return Tysabri to market following its voluntary withdrawal. She discusses how that experience raised her ceiling permanently, and why she has never been able to go back to a smaller version of herself since. She shares how she thinks about building quality culture, identifying real leaders within an organisation, and what it actually takes to lead a team through a product recall at 3am on a Tuesday.

We talk about the following:

• How a JC virus safety crisis at Biogen changed the entire direction of Kim's career

• What she looks for when she joins a new organisation and how she scales quality teams without losing culture

• Her philosophy on 'creative compliance' and why the answer in quality is never just no

• How to lead through warning letters, product recalls, and complete response letters without losing the team

• The knowledge management crisis that follows every reduction in force and why most organisations are not prepared

• What the Vafseo launch felt like after everything Akebia had been through

• Her advice to quality leaders who want to reach the C-Suite

Kimberly Garko is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in the most complex development environments imaginable. She has done this across biologics, oral solid dose, devices, and combination products at every stage from early clinical through to commercial launch.

If you are a quality professional at any stage of your career - whether you are building your first team or trying to figure out what comes after VP - this episode is for you.

Thank you Kim for sharing your incredible journey.

Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR:

• Quality leaders at director and VP level who are navigating high-pressure compliance situations and want a practical framework for crisis response

• Aspiring quality executives who want to understand what it actually takes to move from functional leader to Chief Technical Officer

• Quality managers in biologics, pharma, and biotech who want to build stronger, more resilient teams

• Anyone who has ever had to manage a recall, a warning letter, or a workforce reduction and wants to hear from someone who has been through all three

• Early-career scientists and QC professionals wondering whether there is a path to leadership from the lab bench

Three BLAs. Three companies. One industry-defining challenge.

In this special compiled episode of Let's Talk Quality, Hemish Ilangaratne brings together three quality leaders who have each led their organisation through one of the most demanding transitions in the industry: from clinical development to commercial manufacturing for a cell or gene therapy product.

Jake Trees spent five years at Bristol Myers Squibb leading the quality function through the approval and launch of Abecma and Breyanzi, two of the first commercially approved CAR T cell therapies in the world.

Irving Ford was the first quality hire at the Celgene cell therapy facility in New Jersey, built the QC organisation from nothing, and has since led quality through four BLA approvals across multiple cell therapy companies, most recently at Adaptimmune for the approval of Aucatzyl.

Megan Callan is VP of Quality at Abeona Therapeutics, where she guided the quality team through the FDA approval of Zevaskyn, the first ever approved topical gene therapy for a rare genetic skin disorder.

These are three distinct products, three distinct companies, and three distinct leadership journeys. But across all three conversations, the same themes surface: what it takes to build a quality team from scratch, how to shift the mindset of a clinical organisation towards commercial standards, and what the moment of approval actually feels like after years of sustained effort.

In this episode, you will hear the following:

• Jake Trees on the setbacks on the road to BLA approval, including a refusal to file, cell growth failures during scale-up, and leading through a pandemic while hosting three health authority inspections
• Irving Ford on being the first quality hire at a new commercial cell therapy facility, building a team that grew to over 200 people, and why working in the gray is not a compromise but a core competency in this field
• Megan Callan on taking a quality team from five people to more than 60, coaching a clinical workforce into a commercial mindset, and what it means to empower people to make fast decisions when the patient is waiting

This episode is for anyone who is working towards a first commercial approval, scaling a quality function in cell or gene therapy, or trying to understand what it takes to lead through the most demanding regulatory and operational environment in modern pharma.

Thank you to Jake, Irving, and Megan for sharing their journeys.

Hope everyone enjoys the show.