Dawn Houlihan on Her Journey From Ireland Big Pharma to the Boston Start-Up World — Let's Talk Quality

Dawn Houlihan started out as the person manufacturing teams went quiet around, and spent the next twenty years proving that quality works better as a partner than a police force.

Dawn Houlihan on Her Journey From Ireland Big Pharma to the Boston Start-Up World

In today's episode I was joined by Dawn Houlihan. I wanted to speak to Dawn because she has built a quality function from nothing, and has done it across almost every stage and modality the industry has to offer. She spent half her career with Janssen in Ireland, moved to Scotland and then to Boston, and has since led quality through phase three, commercial approval and cell and gene therapy in two small companies where everything was outsourced.

We talk about:

What quality was actually like on the manufacturing floor in Ireland in the mid two thousands
The mentor who told her to say yes to a project she did not have time for
Switching CDMO in the middle of phase three and still hitting commercial approval
Why saying no to everything is the easy road, and what it costs a small company
Being the first quality hire at Ensoma and building the culture from scratch

Timestamps:

(00:00) Introduction and Dawn's background in pharma

(05:03) Quality's evolution: from policing to partnership

(07:20) Mentorship, Scotland, and the move to Boston

(13:10) Building quality teams in biotech startups

(19:09) Trust, risk, and leading through partnership

(29:29) Building quality from the ground up

(34:16) The future of quality leadership and career advice