Building Quality That Scales, with Laura Singer

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