Luciana Mansolelli on Her First Year as CQO in the CDMO World

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 fixThank 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