Let's Talk Quality

If you are the first quality hire in a startup, your job is not to build everything at once.

Your job is to build the right things first.

That was one of the clearest takeaways from my conversation with Rex Ready on Let’s Talk Quality.

A few practical points he shared stood out:

· Follow the path of the product

· Understand the patient experience

· Focus first on what directly affects patient safety

· Build procedures around processes that already work

· Prioritise quality investment based on stage, modality, and risk

In early-phase environments, it is easy to create a long list of things you would like to have.

An EQMS.

A fuller audit programme.

More formal vendor oversight.

A bigger team.

All of that matters.

But not all of it matters equally on day one.

Strong quality leadership is about judgment. It is about knowing what must be in place now, what can come next, and how to build trust while you do it.

That is especially true in cell and gene therapy, where complexity is high and patient impact is immediate.

A very strong conversation with Rex, and a useful one for anyone building quality in a lean biotech environment.

Timestamps:

(00:00) Introduction

(02:30) From Funeral Director to Biotech: A Unique Path

(05:47) Early Experiences in Quality Control

(07:26) Leadership in Quality: Building Relationships

(09:57) Vision for the Future: Drug Development and Quality

(15:04) Building Effective Relationships in Quality

(17:59) Prioritizing Quality in a Lean Team

(22:58) Planning for Future Growth in Quality

(28:01) Reflections on Cell and Gene Therapy

Quality is changing. The systems are getting smarter, the data is getting bigger, and the people side is still the hardest part.

This week, I sit down with Dennis Rodman, Senior Director of Quality Management Systems and Digital Compliance at Intellia Therapeutics.

Dennis brings a rare perspective to quality. With 13 years at BMS across operations, technical services, and quality, he now helps a gene editing company prepare for its first commercial product.

In this episode, we explore:

• Why quality should be value-add, not a compliance hammer
• What separates companies that get digital transformation right from those that don't
• How to choose the right QMS without getting sold something you don't need
• Why AI isn't delivering the ROI people expected, and what's going wrong
• How to manage change when most people don't want it
• What early-career quality professionals should be doing right now to accelerate

A practical, honest conversation for anyone working at the intersection of quality, systems, and people.

Timestamps:

(00:00) Introduction and Background

(05:04) Quality Management Systems and Operations

(09:59) Stakeholder Engagement and Change Management

(15:12) The Role of IT in Quality Management

(21:02) Cultural Shifts and Data Sharing

(23:34) Advice for Aspiring Quality Leaders

(26:01) Future of Biotech and Quality Management

From accidental quality professional to global quality leader - Valerie Brown's story is one of courage, curiosity, and conviction.

In today's episode I was joined by Valerie Brown, Head of Global Quality Assurance and Compliance at Thermo Fisher Scientific's Clinical Research Group.

I really wanted to speak to Valerie because she brings something different to the quality leadership conversation. Yes, she has held senior quality roles across innovator companies, CDMOs, and now one of the largest CROs in the world. But what makes her story compelling is how she got there - and what she learned along the way.

Valerie didn't plan to work in quality. At 22, she was asked to be a scribe for an FDA inspection. The host fell ill on the day. She stepped in - no preparation, no safety net - and handled it.

Someone told her she had a knack for it. She wasn't sure she agreed. She still wanted to be in the lab, in manufacturing, doing what she knew. But that moment planted a seed.

What followed was a career that took her across CDMOs, innovator companies including Gilead Sciences, and now Thermo Fisher - where she leads global quality assurance and compliance for the clinical research group. She has sat on both sides of the table, as sponsor and as service provider, and that experience shapes everything about how she leads.

We talk about the following:

• How Valerie accidentally became a quality professional, and why that unplanned start shaped everything that followed
• What it felt like to host an FDA inspection at 22, with no preparation and no safety net
• Her philosophy of servant leadership and what it really means to lead with empathy in a regulated environment
• The challenge of transforming a fragmented quality organisation into a connected, strategic function at Thermo Fisher
• The difference between working on the innovator side versus the CRO side - and the unique skill set the latter demands
• Why speed and quality are not in conflict, and how embedding quality by design from the outset actually accelerates delivery
• Her approach to talent development - why she prefers to grow leaders from within and how she identifies that potential early
• The growing importance of AI and digital governance in regulated environments, and why quality professionals need to engage with these tools now
• What keeps her up at night heading into 2026 - from talent gaps to trial complexity to the pace of regulatory change
• The advice she would give her younger self, and what she believes every aspiring quality leader needs to understand

Valerie Brown is a highly accomplished global quality leader whose career is a masterclass in adaptability, influence, and patient-centric thinking. She leads with purpose, develops people with intention, and approaches every challenge with the mindset of a problem solver - exactly the kind of leader our industry needs more of.

Thank you Valerie for sharing your incredible journey. Hope everyone enjoys the show!

Timestamps:

(00:00) Introduction to Valerie Brown and Her Journey

(02:59) Valerie's Leadership Philosophy and Style

(06:00) Transitioning from Innovator to CRO: Insights and Challenges

(11:04) Quality Assurance in Clinical Research: A New Perspective

(13:58) Building a Quality Organization: Strategies and Goals

(20:55) The Role of AI in Quality Management

(24:18) Future Goals and Challenges in Quality Assurance

(29:04) Advice for Aspiring Quality Leaders

What if the leader you become is shaped less by your title, and more by the life you’ve lived?

In today's episode I was joined by Dana Adcock, Quality Consultant and former Senior Director of Quality Systems.

I really wanted to speak to Dana because she brings something different to the quality leadership conversation. Yes, she has decades of experience leading global audit and quality systems teams. But what makes her story powerful is how openly she connects her personal journey to the leader she has become.

Dana shares how growing up as an adult child of alcoholics shaped her early career. Avoiding conflict. Playing small. Hiring people who thought like her. Shying away from leadership roles despite being promoted into them.

Over time, through personal hardship, therapy, motherhood, and reflection, she stepped into leadership differently. More intentional. More courageous. More authentic.

We talk about the following:

· How early life patterns show up in leadership behaviour

· Why many capable professionals avoid management roles

· Moving from conflict avoidance to confident, purpose-led leadership

· Building diverse teams instead of hiring people “just like you”

· The mindset shift that happened during her “midlife awakening”

· How adopting her daughter Abby changed how she leads and advocates

· The link between personal resilience and professional courage

· Showing up authentically on LinkedIn and why it felt terrifying

· What “living the fourth quarter intentionally” really means

· Advice for quality professionals who feel pressure to hide parts of themselves

Dana is a thoughtful, courageous and deeply reflective leader who demonstrates that strength in quality leadership isn’t about technical authority alone – it’s about self-awareness, integrity and the willingness to grow.

Thank you Dana for sharing your incredible journey.

Hope everyone enjoys the show!

Timestamps:

(00:00) Introduction

(01:43) Early Challenges in Career Growth

(10:37) Midlife Awakening

(18:06) Embracing Authenticity in Leadership

(28:08) The Importance of Being Seen

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:

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

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!

In today's episode, Hemish was joined by Andrew Jones, former VP, Commercial Quality at Iovance Biotherapeutics.

Andrew is one of the few quality leaders who has actually built a cell therapy site from construction through to BLA submission, FDA inspection and final approval – all while growing and upskilling a team who were doing it for the first time.

Andrew’s career spans 30+ years across biopharma, biotech, cell and gene and commercial launches.

He’s very intentional about principles - listen first, build trust, don’t lie in front of an inspector - and he’s done this in high-pressure, time-sensitive environments where approval is the company’s lifeline.

He talks about the following:

• Moving from validation into site QA at a CDMO and how that set the foundation for future inspection work.

• Lessons from Andrew’s early BLA work at J&J and negotiating specs with R&D and FDA.

• The reality of building a cell therapy facility during the pandemic and getting it inspection ready.

• Why small and mid-sized biotechs underestimate the time vs patience problem in inspection readiness.

• How to break inspection readiness into risk-based subcomponents instead of ‘boiling the ocean’.

• The core inspection principles Andrew teaches his teams (listen first, build trust, never lie).

• How to train a team that has never sat in front of an FDA investigator before.

• The mindset shift from clinical to commercial in cell therapy – and why turnaround time becomes everything.

• Leading at a steady temperature through BLA, inspections and approval.

• Creating a culture where people feel safe to speak up, challenge and improve systems.

Andrew is a calm, values-led quality leader who knows how to get therapies over the line without losing the team in the process.

Thank you Andrew for sharing your incredible journey.

Hope everyone enjoys the show!