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

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

Quality culture isn't built by SOPs. It's built in the small moments when a leader reinforces the right behaviour or lets the wrong one slide.
Speaking the Language of the Business, with Jamey Lindholm.
In today's episode I was joined by Jamey Lindholm, Vice President of Quality at R1 Therapeutics. I really wanted to speak to Jamey because she has led Quality through nearly every stage a career in this industry can throw at you: a first-in-class FDA approval at Seres Therapeutics, an acquisition by Merck KGaA at Springworks, and now building a Quality function completely from zero as R1's very first Quality hire. She has strong, hard-won views on how to get each of those right.
Jamey's journey started almost by accident. She fell into a QC chemistry job at a small biotech straight out of university, got laid off a year later when the company ran out of funding, and then spent the next 20 years at Biogen, where she built the foundation of what she now calls "what good looks like" in Quality. From there she moved to Seres Therapeutics, where she led end to end Quality through the first FDA approval of a microbiome-derived oral therapy, then to Springworks through its acquisition by Merck KGaA, and now to R1 Therapeutics as its first Quality hire.
What comes through across the whole conversation is a leader who has thought deeply about the difference between compliance and culture. Jamey is clear that Quality earns its seat at the leadership table not by enforcing SOPs, but by translating compliance into risk, into regulatory consequence, into business decisions that leadership teams actually understand. She is equally clear that the industry has a visibility problem. Almost nobody chooses Quality as a career at school, and she believes that is something the industry has an obligation to fix.
We talk about the following:
Why 20 years at a large pharma company can make the move into a startup harder, not easier
The difference between managing Quality operations and being responsible for end-to-end Quality at a small company
Why "quality risks are business risks" changes how a leadership team makes decisions
What actually builds quality culture, and why it isn't SOPs
The moment Seres received FDA approval for Vowst, and why it felt different from anything Jamey experienced at Biogen
Why it's never too early to bring in a permanent Head of Quality, and what that decision signals about a company's culture
Why Quality is invisible as a career choice to STEM students, and what the industry can do about it

Jamey is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Jamey for sharing your incredible journey. Hope everyone enjoys the show.
WHO THIS EPISODE IS FOR
A Head of Quality or VP Quality building a function from scratch at a startup
A big pharma quality professional considering a move into biotech
A founder or CEO deciding when to bring in a permanent Head of Quality
A quality manager trying to build genuine culture, not just documentation
A STEM student or early-career scientist who has never considered Quality as a career path

Timestamps:
(00:00) Introduction to Jamey Lindholm and Her Career Journey
(02:41) Transitioning from Big Pharma to Startups
(05:14) Navigating Quality in Complex Environments
(07:38) The Role of Quality in Business Strategy
(10:16) Building a Quality Culture in Startups
(13:14) Hiring for Quality in Startups
(15:42) The Visibility of Quality Careers in STEM
(18:29) Demystifying Quality for Future Generations
(21:12) Inspiring the Next Generation in Quality Science
(22:40) The Emotional Impact of FDA Approvals
(26:46) The Importance of Quality Leadership in Startups
(31:30) Building a Quality Culture from the Ground Up
(34:50) Advice for Future Quality Professionals
(37:03) Making the Case for a Career in Quality

Twenty years at Merck, then a leap into academia and psychedelic medicine - here is how Dawn Lundin built a quality career on instinct.
Dawn Lundin on the big pharma habits you have to unlearn in a startup.
In today's episode I was joined by Dawn Lundin, founder of her own quality consultancy and a fractional Head of Quality across biotech and psychedelic-medicine companies. I really wanted to speak to Dawn because her path is nothing like the typical quality leader's. She didn't stay inside big pharma and climb one ladder. She spent twenty years at Merck, then walked into academia, then into one of the most stigmatised fields in medicine, and she made each move work.
Dawn started as a bench chemist and grew through GLP, clinical packaging, GCP auditing and pharmacovigilance, eventually heading up issues management and co-authoring the first quality manual for Merck's research division. Then, on the morning of her twentieth anniversary, she resigned. She moved to the University of Pennsylvania to build fit for purpose quality systems for both sponsor and site research, a system still in use today. From there she stepped into psychedelic medicine for mental health, a move driven as much by personal loss as by professional curiosity.
What runs through Dawn's whole story is a refusal to lead by importing an old playbook. In a smaller, faster environment she learned to do quality with far less, to put relationships before procedures, and to build trust before she changed a single thing. Her line for it has stuck with me: she did quality "one cup of coffee at a time."
We talk about the following:
Why she left twenty years at Merck on the exact morning of her anniversary
The big pharma habits leaders have to unlearn in academia and startups
How to build a fit for purpose quality system with a fraction of the resources
Why relationships, not procedures, carry a quality programme in a small organisation
The personal story that drew her into psychedelic medicine and mental health

Dawn Lundin is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Dawn for sharing your incredible journey. Hope everyone enjoys the show.
WHO THIS EPISODE IS FOR
Quality leaders moving from big pharma into a startup, scale-up or academia
Hiring managers building a first quality team and weighing up big pharma candidates
Early-stage biotech founders who need fit for purpose quality without the overhead
Quality professionals weighing a bold or unconventional career move
Anyone drawn to how mental health and psychedelic medicine are being built responsibly

Timestamps:
(00:00) - Introduction to Dawn Lundin
(01:15) - Dawn's Journey into Science and Quality
(05:05) - Career Growth at Merck
(11:16) - Transitioning from Big Pharma to Academia
(17:34) - Navigating Startup Challenges
(22:54) - Current Consultancy and Future Aspirations