In today’s episode, Hemish was joined by Anthony Mire-Sluis, Head of Global Quality at Gilead.

Tony because has lived quality from every angle - UK government and regulatory work, a stint at the FDA, and then senior global leadership roles in major pharma. That perspective is rare, and it shows in how he builds teams and drives change.

Tony’s journey is a brilliant example of how strong quality leadership is less about having all the answers, and more about building trust, listening properly, and creating systems that let people do their best work.

He talks about the following:

• How Tony’s science background (immunology, genetics, and a PhD) shaped the way he leads quality

• What 10 years in government taught him about great vs poor regulatory filings - and why he moved into industry

• The difference between leading a US-centric quality organisation vs a truly global one

• Why building a trusted leadership team is the non-negotiable for running global quality at scale

• How Tony uses his first 90 days: listening, due diligence, and getting under the skin of the culture

• Why he starts transformation from the shop floor - not from the senior leadership layer

• Digital and AI in quality: fix the process first, then digitise (otherwise you just create a clunky digital version)

• How to reduce firefighting and move quality from reactive to proactive - with better workflows and connected systems

• Managing resistance to change and bringing people along early so adoption sticks

• Advice for aspiring quality leaders: networking, knowing yourself, and broadening your experience across quality

Anthony Mire-Sluis is an authentic, people-first quality leader with a rare blend of regulatory depth and big pharma operational experience - and he’s exactly the kind of leader who makes quality a true enabler of the business.

Thank you Tony for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode, Hemish was joined by Ed Armstrong and Jon Voss, two Quality leaders who’ve both worked across early-stage, clinical, and complex biotech environments.

Ed and Jon share what they’re seeing on the ground - from funding pressure and modality shifts, to how regulators are engaging, and where Quality leaders are gaining (or losing) influence.

They talk about the following:

1. The current state of pharma and biotech, and whether the market has really bottomed out
2. Which modalities and parts of the market feel resilient, and which are still struggling
3. How FDA leadership changes are (and aren’t) showing up in day-to-day work
4. The shift toward written-only FDA interactions and what that means for sponsor–agency relationships
5. Whether regulators are prioritising speed or risk, and how that tension plays out
6. Where AI and digital tools are genuinely adding value today, versus where there’s still a lot of noise
7. How Quality has evolved from “policing” to partnership over the last 20 years
8. Why pragmatic, phase-appropriate Quality systems matter more than perfection
9. Burnout in senior Quality leaders and the risk of doing too much with too few people
10. What separates Quality leaders who are listened to from those who are merely tolerated
11. What the strongest Quality teams will be doing differently by the end of 2026

Ed and Jon bring a huge amount of perspective, humility, and real-world insight to this discussion. This is a conversation for anyone leading Quality through uncertainty and trying to balance patient safety, speed, and sustainability.

Hope everyone enjoys the show!

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.