This week on Let’s Talk Quality, we’re joined by Elisabeth Hutchins, Senior Director of Quality at Upstream Bio, for a conversation focused entirely on one theme:

How quality professionals make the transition from tactical execution to strategic leadership.

In this episode, Elisabeth shares:

• What changes as a company enters Phase 2 and Phase 3
• The moment she realised she needed to stop firefighting and start planning
• How she built the quality team around her to enable strategic thinking
• The soft skills that shape strong future QA leaders
• How to balance urgent deliverables with long-term quality strategy
• Why confidence is essential before others trust you as a strategic partner

Elisabeth brings an honest and practical perspective that will resonate with managers and directors looking to step into bigger leadership roles.

A highly insightful discussion for anyone looking to evolve into a strategic quality leader.

This week, Hemish is joined by Ashley Preston, SVP of Regulatory, Quality and Medical Writing at Blossom Hill Therapeutics, for a conversation about what it really takes to win hearts and minds early in quality leadership.

Ashley took an unconventional path into QA, stepping into his first Quality leadership role after a long career in Regulatory Affairs.

Because of that, he’s had to lead through something far more important than technical depth: communication, trust, and people.

In the episode, Ashley shares:

• Why he moved from Regulatory into Quality leadership
• How to build trust quickly when you’re new to QA
• How leaders can empower technical experts and still influence effectively
• Practical ways to build quality systems and culture in a small biotech
• Why communication, self-awareness and soft skills matter more than ever
• How quality can earn a stronger, more strategic voice at the executive table

Ashley’s perspective is grounded, pragmatic, and incredibly relevant for leaders in emerging and clinical-stage biotech.

#QualityLeadership #Biotech #RegulatoryAffairs #QualityCulture #LetsTalkQuality

From Greenfield to GMP.

In today's episode, Hemish is joined by Kyle Powell, Head of Quality at Ratio Therapeutics.

Kyle is a great example of the next generation of quality leaders who are building from the ground up - combining technical depth with a modern, empathetic approach to leadership.

Kyle’s career is an impressive story of growth, moving from regulatory consulting into radiopharmaceuticals, helping to stand up new facilities, and now leading the full quality build-out for Ratio’s 65,000 sq ft Greenfield site in Salt Lake City.

He talks about the following:

• How Kyle transitioned from regulatory strategy into quality leadership
• What it takes to scale a quality system in radiopharma from zero to commercial readiness
• Moving from tactical work to strategic thinking as a leader
• Building credibility and influence as a young quality leader
• The importance of empathy and communication in leading teams
• How to justify resources and headcount in a startup environment
• Creating a digital-first, paperless quality function from day one
• Lessons from managing culture and mindset through growth
• The softer skills that separate effective leaders from technical experts
• Advice for early-career professionals aiming to step into leadership roles

Kyle is an ambitious and thoughtful leader - pragmatic, forward-thinking, and people-first.

Thank you, Kyle, for sharing your incredible journey.

Hope everyone enjoys the show!