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