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

Luciana Mansolelli spent twenty years on the sponsor side. One question from a board chairman moved her to a CDMO.

Luciana Mansolelli on her first year as CQO in the CDMO world.

In today’s episode I was joined by Luciana Mansolelli, Chief Quality Officer at Minaris Advanced Therapies. I wanted to speak to Luciana because she has now led quality on both sides of the same relationship - Novartis and J&J on the sponsor side, and now a 200-person global quality organisation across the US, Germany and Japan.

We talk about:

• The moment she realised she had stopped learning, and why she left

• Why framing speed against quality is the wrong model in advanced therapies

• How she structured a global quality team around the science rather than the org chart

• What she assesses for when she hires, beyond technical competence

• Turnover in the CDMO world, and why she thinks capability is the fix

Thank you Luciana for sharing your journey.

Timestamps:

(00:00) Introduction to Luciana Monsolelli

(01:01) Journey into Pharmaceutical Sciences

(02:41) The Evolution of Quality in Pharma

(05:32) Transitioning from Big Pharma to CDMO

(08:30) Challenges in the CDMO Landscape

(14:00) Building a Quality Culture at Minaris

(19:00) Talent Management and Capability Development

(27:00) Leadership Style and Team Dynamics

(37:00) Future Aspirations in Advanced Therapies

Season Four is at its halfway point, so instead of a guest this week I’ve gone back over the conversations so far and pulled out the theme that came up most often.

The quality leader whose main function is to say no is finished.

This episode is four clips from Season Four guests on that theme, with my own thoughts in between.

I also talk about why I think this matters for your career and not just for your working relationships, which comes from the other half of my week, placing quality leaders and hearing what hiring managers are actually asking for.

Get in touch

If you’re going through that step up at the moment, I’d be interested to hear about it. Find me on LinkedIn, or book a conversation here: https://calendly.com/h-ilangaratne/meeting-with-hemish-rx-group

If there’s a topic you’d like covered on a future solo episode, send it over.

Timestamps:

(00:00) - Intro - Halfway Through Season Four

(01:50) - The Old Reputation - Tim Mitchell

(03:30) - Hemish's Take - Reputation vs. Reality

(04:23) - Saying No Is the Easy Option - Kim Garko

(05:51) - Hemish's Take - The Career Angle

(07:21) - Translating Risk for the Business - Jamey Lindholm

(10:02) - Hemish's Take - Practical Application

(10:59) - Partnership Over Policing - Rex Ready

(14:21) - Closing Thoughts - What This Means for Quality Leaders