Episode

Building Quality That Scales, with Laura Singer

Podcast
Let's Talk Quality
Published
May 19, 2026
Duration seconds
2129
Processing state
not_requested
Canonical source
https://rx-group.io/captivate-podcast/building-quality-that-scales-with-laura-singer
Audio
https://episodes.captivate.fm/episode/4d0cd211-82fd-46a6-89c9-44f26edfab41.mp3
JSON
/v1/public/podcasts/let-s-talk-quality-6567110/episodes/building-quality-that-scales-with-laura-singer
Markdown
/podcast/let-s-talk-quality-6567110/building-quality-that-scales-with-laura-singer.md

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Summary

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…