# The First 90 Days of Building Quality in a Startup with Theresa Donegan

Page: https://stenobird.com/podcast/let-s-talk-quality-6567110/the-first-90-days-of-building-quality-in-a-startup-with-theresa-donegan
Text version: https://stenobird.com/podcast/let-s-talk-quality-6567110/the-first-90-days-of-building-quality-in-a-startup-with-theresa-donegan.md
Podcast: [Let's Talk Quality](https://stenobird.com/podcast/let-s-talk-quality-6567110)
Published: 2025-11-05T16:00:00+00:00
Episode link: https://rx-group.io/captivate-podcast/the-first-90-days-of-building-quality-in-a-startup-with-theresa-donegan
Audio file: https://episodes.captivate.fm/episode/a82c02e4-c357-4a2d-8c56-eb0b3d421001.mp3
Processing state: not_requested
JSON: https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/the-first-90-days-of-building-quality-in-a-startup-with-theresa-donegan
Duration seconds: 2306

## Resource

In today's episode, Hemish was joined by Theresa Donegan, VP of Quality at Climb Bio. Theresa has spent the last few years helping biotech startups build quality from the ground up - often as a team of one.  With 30 years’ experience across every GxP environment, she brings a rare perspective on what it takes to move from large pharma structure to biotech agility, while still protecting compliance and patient safety. Theresa’s career began in the QC lab before moving through GLP, GCP, and GMP roles in large and small companies, CROs, and now Climb Bio. Her path is a masterclass in adaptability, and in today’s startup environment, her insights couldn’t be more relevant. She talks about the following: • How Theresa’s career evolved from QC lab work to VP of Quality leadership • The mindset shift from big pharma to biotech startups • What the first 30/60/90 days look like when you’re building quality from scratch • How to balance pragmatism, speed, and compliance in early-stage biotech • How to use consultants effectively • The right time to bring in permanent quality leadership  • What “good” looks like in an early-stage quality system • How to align leadership teams and departments when everything is moving fast • How to spot red and green flags when joining a startup • The key soft skills quality professionals must build early in their careers • How to prioritise your first three hires when you finally have budget Theresa is an incredibly grounded and thoughtful leader, combining technical depth with an empathetic leadership style that every quality professional can learn from. Thank you Theresa for sharing your incredible journey. Hope everyone enjoys the show!

## Actions

- request_transcript: `POST https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/the-first-90-days-of-building-quality-in-a-startup-with-theresa-donegan/transcription-requests` — Idempotently request low-priority transcript generation for this episode.
- read_markdown: `GET https://stenobird.com/podcast/let-s-talk-quality-6567110/the-first-90-days-of-building-quality-in-a-startup-with-theresa-donegan.md` — Read the agent-friendly Markdown representation of this episode resource.

A page view does not enqueue transcription. Agents should invoke `request_transcript` explicitly when they need this episode processed.

## Transcript

Full transcripts are not published on public pages unless there is a clear rights basis.