Let's Talk Quality5 Marras 2025

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

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!

Tämä jakso on lisätty Podme-palveluun avoimen RSS-syötteen kautta eikä se ole Podmen omaa tuotantoa. Siksi jakso saattaa sisältää mainontaa.

Jaksot(74)

Swetha Krishnan on her journey from Individual Contributor to Inspiring People Leader

She came to the US with her first year's tuition and figured the rest out from there. What followed is one of the most grounded quality leadership journeys I have heard - and one we felt was worth bri...

26 Touko 41min

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 w...

19 Touko 35min

From Virologist to CTO: Leading Quality Through Crisis, with Kimberly Garko

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 rea...

12 Touko 37min

Three BLAs, Three Journeys, with Irving Ford, Megan Callan, and Jake Treese

Three BLAs. Three companies. One industry-defining challenge.Jake Trees, Irving Ford, and Megan Callan on What It Really Takes to Cross the Commercial Line in Cell and Gene TherapyIn this special comp...

7 Touko 34min

The Non-Linear Path to Quality Leadership, with Cinta Burgos

The non-linear path is often the most powerful one.Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets.In today's episode I was joined by Cinta Burgos, Senior Vice President o...

28 Huhti 28min

From the Graveyard Shift to the Frontier of Cell Therapy, with Mike Ruane

From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear.In...

21 Huhti 35min

Laurie Adami on Life After CAR-T, and the Reality Patients Still Face

CAR-T Saved Her Life. Why Can’t Most Patients Access It?In today’s episode I was joined by Laurie Adami, cancer survivor, patient advocate, and one of the most impactful voices I’ve had on the podcast...

14 Huhti 38min

How to Drive KPI's the Right Way in Global Quality, with Burak Begen

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 wan...

31 Maalis 29min