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