In this episode, Hemish was joined by Karin von Hodenberg, VP of Quality at Monte Rosa Therapeutics.

Karin has repeatedly built quality systems from the ground up across med device and biotech, and she translates that experience into practical, phase-appropriate guidance for early teams.

Karin’s journey is anything but typical: a business background, supply chain and Lean Six Sigma Black Belt training led her into quality at GE Healthcare and Philips, before moving into biotech with bluebird bio during rapid growth. She’s since led in several startups and now at Monte Rosa, where she’s implemented validated systems early and embedded a genuine culture of quality across GxP.

She talks about the following:

• Why a non-traditional path (business → supply chain → Six Sigma) can be a superpower in Quality.
• From paper to validated eQMS: how bluebird bio migrated training & documents and why they verified 100% of records.
• Trigger points for moving beyond paper: signs you’re outgrowing a doc control room and how to stand up DMS/LMS/LIMS early.
• Phase-appropriate, risk-based thinking: using data, science and regulations - without becoming a blocker.
• Making quality ‘cool’: education, storytelling, and visible sponsorship from ELT.
• Leading without fear: replacing “inspection readiness day” with “inspection readiness every day.”
• Critical thinking over checkbox compliance: hiring, interview questions, and building the muscle across teams.
• Working with functional heads: cadence of 1:1s, being a partner (not a gate), and influencing through solutions.
• Roadmaps that breathe: Karin’s 3‑year plan, quarterly outcomes, and how transparency sustains engagement in uncertainty.
• AI pragmatism in quality: where note-taking and drafting help now - and where human judgment still rules.

Thank you Karin for sharing your incredible journey.

Hope everyone enjoys the show!