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