{"podcast":{"title":"Let's Talk Quality","slug":"let-s-talk-quality-6567110","podcast_index_feed_id":6567110,"rss_url":"https://feeds.captivate.fm/lets-talk-quality/","website_url":"https://rx-group.io/","image_url":"https://artwork.captivate.fm/1ce986d0-acc5-4088-8268-af6f5dfbb463/eyGXJDmcc8NoXmM0aMUmvptV.png","author":"Hemish Ilangaratne","episode_count":75,"summary":"“Let’s Talk Quality” is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries to share their knowledge, experiences, and strategies for achieving quality excellence. Join us on a journey of discovery as we unravel the importance of quality and its profound impact on businesses and society. Get ready to engage in insightful discussions, gain valuable perspectives, and unlock the secrets to fostering a culture of quality in every aspect of life. Tune in and let’s embark on this exciting quality-driven adventure together.","last_synced_at":"2026-07-08T02:17:22.072881+00:00","page_url":"https://stenobird.com/podcast/let-s-talk-quality-6567110"},"episode":{"title":"Building phase-appropriate quality systems early, and treating inspection readiness as an everyday habit with Karin von Hodenberg","slug":"building-phase-appropriate-quality-systems-early-and-treating-inspection-readiness-as-an-everyday-habit-with-karin-von-hodenberg","published_at":"2025-10-08T16:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-talk-quality-6567110/building-phase-appropriate-quality-systems-early-and-treating-inspection-readiness-as-an-everyday-habit-with-karin-von-hodenberg","show_page_url":"https://stenobird.com/podcast/let-s-talk-quality-6567110","url":"https://rx-group.io/captivate-podcast/building-phase-appropriate-quality-systems-early-and-treating-inspection-readiness-as-an-everyday-habit-with-karin-von-hodenberg-","audio_url":"https://episodes.captivate.fm/episode/98e30287-8c3a-4c99-b995-df0c322e313e.mp3","summary":"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. Karin is…","meta_description":"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 g…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2330,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/building-phase-appropriate-quality-systems-early-and-treating-inspection-readiness-as-an-everyday-habit-with-karin-von-hodenberg/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-talk-quality-6567110/building-phase-appropriate-quality-systems-early-and-treating-inspection-readiness-as-an-everyday-habit-with-karin-von-hodenberg.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}