# Luciana Mansolelli on Her First Year as CQO in the CDMO World Page: https://stenobird.com/podcast/let-s-talk-quality-6567110/luciana-mansolelli-on-her-first-year-as-cqo-in-the-cdmo-world Text version: https://stenobird.com/podcast/let-s-talk-quality-6567110/luciana-mansolelli-on-her-first-year-as-cqo-in-the-cdmo-world.md Podcast: [Let's Talk Quality](https://stenobird.com/podcast/let-s-talk-quality-6567110) Published: 2026-08-25T11:45:00+00:00 Episode link: https://rx-group.io/captivate-podcast/luciana-mansolelli-on-her-first-year-as-cqo-in-the-cdmo-world Audio file: https://episodes.captivate.fm/episode/739292e0-eb72-4cf1-a957-4bb49b58e38a.mp3 Processing state: not_requested JSON: https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/luciana-mansolelli-on-her-first-year-as-cqo-in-the-cdmo-world Duration seconds: 2353 ## Resource 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 ## Actions - request_transcript: `POST https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/luciana-mansolelli-on-her-first-year-as-cqo-in-the-cdmo-world/transcription-requests` — Idempotently request low-priority transcript generation for this episode. - read_markdown: `GET https://stenobird.com/podcast/let-s-talk-quality-6567110/luciana-mansolelli-on-her-first-year-as-cqo-in-the-cdmo-world.md` — Read the agent-friendly Markdown representation of this episode resource. A page view does not enqueue transcription. Agents should invoke `request_transcript` explicitly when they need this episode processed. ## Transcript Full transcripts are not published on public pages unless there is a clear rights basis.