Episode
Luciana Mansolelli on Her First Year as CQO in the CDMO World
- Podcast
- Let's Talk Quality
- Published
- Aug 25, 2026
- Duration seconds
- 2353
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Summary
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