Let's Talk Quality

In today's episode, Hemish was joined by Theresa Donegan, VP of Quality at Climb Bio.

Theresa has spent the last few years helping biotech startups build quality from the ground up - often as a team of one.

With 30 years’ experience across every GxP environment, she brings a rare perspective on what it takes to move from large pharma structure to biotech agility, while still protecting compliance and patient safety.

Theresa’s career began in the QC lab before moving through GLP, GCP, and GMP roles in large and small companies, CROs, and now Climb Bio. Her path is a masterclass in adaptability, and in today’s startup environment, her insights couldn’t be more relevant.

She talks about the following:

• How Theresa’s career evolved from QC lab work to VP of Quality leadership

• The mindset shift from big pharma to biotech startups

• What the first 30/60/90 days look like when you’re building quality from scratch

• How to balance pragmatism, speed, and compliance in early-stage biotech

• How to use consultants effectively

• The right time to bring in permanent quality leadership

• What “good” looks like in an early-stage quality system

• How to align leadership teams and departments when everything is moving fast

• How to spot red and green flags when joining a startup

• The key soft skills quality professionals must build early in their careers

• How to prioritise your first three hires when you finally have budget

Theresa is an incredibly grounded and thoughtful leader, combining technical depth with an empathetic leadership style that every quality professional can learn from.

Thank you Theresa for sharing your incredible journey.

Hope everyone enjoys the show!

From £9,000-a-year QC analyst to global quality leader - Iain Rusling’s story is a masterclass in soft‑skills, grit and making quality a strategic enabler.

In today's episode, Hemish was joined by Iain Rusling, a global Quality & Operations leader and former Chief Quality Officer.

Iain's journey - from QC benches in the UK to leading international, matrixed teams in Europe, captures the mindset, communication, and cross‑functional collaboration required to turn quality into a competitive advantage.

Iain began in QC at small biotechs, built facilities and quality systems, moved through technology transfer and inspections, and later led global/EMEA functions from Munich.

Along the way he faced setbacks, loss, consulting chapters, and major inflection points - all of which shaped a people‑centered leadership style that keeps him on the shop floor, not behind a desk.

He talks about the following:

• Starting in QC on £9,000 a year and the mindset that accelerated his career
• Building an oligonucleotide facility from scratch and what it taught him about influence without authority
• Moving from site roles to global, matrixed leadership - how to earn trust across borders and cultures
• Inspections and licenses (FDA/MHRA) as leadership pressure tests
• Why quality must be represented in the boardroom - and how to make the case
• Turning ‘quality as a cost’ into ‘quality as continuity of revenue’
• Practical ways quality leaders can humanise their function: walk the floors, speak operations, build relationships
• Interview advice for QA leaders: questions to uncover culture, investment and phase‑appropriate systems
• Clinical → Commercial transitions: where companies get stuck and how advisory/fractional quality leaders help
• AI realism: useful for trends and signals, but it can’t replace human judgment on the shop floor

Iain is a thoughtful, pragmatic leader who combines technical depth with empathy, candour and a relentless focus on relationships.

Thank you Iain for sharing your incredible journey.

Hope everyone enjoys the show!

AI is here - and it’s already changing the way we think about compliance, quality, and productivity in biotech.

In today's episode Hemish was joined by Subbu Viswanathan, Head of Compliance at DashBio.

Subbu because is one of the few quality leaders who has been building and integrating AI into quality systems for over a decade – long before it was mainstream. And he’s now leading quality and compliance at a tech-driven CRO, where speed and automation are core to the model.

Subbu’s journey spans shop floor experience, software development, cloud QMS implementation, startup failures, AI audit tools, and now redefining what a modern bioanalytical CRO can be.

He talks about the following:

• What quality looks like when you build a company from scratch with AI and automation at the core.

• How to move fast without breaking compliance.

• What GLP and GCP readiness really involves in a fast-paced environment.

• How to use LLMs and automation to handle audit questionnaires and generate CAPAs.

• Why most GenAI pilots are failing in biotech.

• How to think clearly about the noise vs. signal when it comes to AI tools.

• Why quality leaders need to be AI-literate to stay relevant.

• The slow death of traditional entry-level QA jobs – and what might replace them.

• Why AI won’t take your job – but someone using AI better than you will.

• What a good quality mindset looks like in the age of digital transformation

Subbu is a brilliant thinker who brings clarity, experience, and grounded insight to an often confusing topic.

Thank you Subbu for sharing your incredible journey.

Hope everyone enjoys the show!

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 a thoughtful, pragmatic Quality leader who balances compliance with business value - bringing people with her as she builds systems that last.

Thank you Karin for sharing your incredible journey.

Hope everyone enjoys the show!

Creating order from chaos: how a VP of Quality builds trust, leads through constraints, and keeps teams focused on patients.

In today's episode Hemish was joined by Sep Naraghi, Vice President of Quality & Regulatory Affairs at Cellularity Inc.

Sep has led quality in both Big Pharma and startups and has a practical, people-first approach to building trust, making trade-offs, and delivering under resource constraints.

Sep’s journey is anything but linear: from QC in generics to supplier quality at Boehringer Ingelheim, to leading quality and regulatory in a startup. His leadership philosophy is anchored in two values—trust and order—and he’s candid about how feedback early in his career reshaped how he manages one-to-ones, builds transparency, and partners across the business.

We talk about the following:

• Early path: QC in generics to supplier quality at Boehringer Ingelheim and an accelerated step into leadership.
• The two values that guide him—trust and order—and how childhood experiences shaped them.
• What changed in the industry: from “quality as police” to quality embedded early and driving value.
• Practical ways he learned softer skills: asking more questions, reading the room, and focusing on people in 1:1s.
• Big Pharma vs startup: resource constraints, creative problem-solving, and prioritising the ‘must-haves’.
• Keeping culture strong under pressure: transparency, bi-weekly team forums, and cross-functional partnership.
• Managing up and across: using a ‘ladder of inference,’ lunch-and-learns, and making the logic visible.
• Hiring and fit for startups: flexibility, curiosity, blunt-but-respectful dialogue, and support from your boss.
• Creating order from chaos: bringing structure to reach IND/BLA milestones without losing speed.
• Advice for aspiring leaders: lean into discomfort; empathy over ego; and build trust before you need it.

Sep Naraghi is a thoughtful, values-led leader who turns ambiguity into execution, champions transparency, and builds teams that do the right thing for patients and the business.

Thank you Sep for sharing your incredible journey.

Hope everyone enjoys the show!

From rock guitarist to VP of Corporate Quality, Tony shows how principles, clear choices, and modern tools like AI can level-up how quality leaders think and operate.

In today's episode, Hemish was joined by Tony Jones, Vice President, Corporate Quality at Syneos Health.

Tony’s path is anything but typical: NHS clinical biochemistry, clinical pharmacokinetics at Beecham/GSK, a move to France, and then landing, almost by accident, in QA leadership in New Jersey. He went deep on GLP and data principles, published prize-winning work, and has since focused on education, strategy, and the creative application of regulation to help teams do their best work.

He talks about the following:

• The unconventional route from aspiring guitarist to Director of QA and beyond.
• What clinical labs taught him about data and why that matters in pharma/biotech quality.
• GLP as a canvas: distilling regulation into simple, durable principles.
• Data integrity beyond acronyms: accuracy, completeness, consistency and study reconstruction.
• Why strategy is a set of choices (Roger Martin) and leaving room for emergence (Mintzberg).
• Decision-making lenses leaders can actually use: broaden options, avoid false binaries, and think before acting.
• Critical thinking by design: two questions - “What’s going on?” and “What should I do about it?”.
• AI in the quality toolkit: daily use cases, custom agents, and why bottom‑up experimentation matters.
• Training and culture: shifting from static courses to on-demand, problem-first learning.
• Career advice: learn continuously, evidence change, take morning walks, make space for reflection.

Tony is a thoughtful, principles‑driven quality leader who blends scientific depth with practical strategy and a genuine passion for learning and teaching.

Thank you Tony for sharing your incredible journey.

Hope everyone enjoys the show!

In this week's episode, Hemish was joined by Scott Pherson, Senior Director of Quality Assurance at AS2 Bio.

Scott has made the transition from big pharma to startup biotech three times. And now, he’s building quality from scratch at a company that hasn’t even dosed a patient yet.

Scott has nearly 20 years’ experience across QC, operations, and quality leadership, having worked at Biogen, Shire, AvroBio and more. Now, as the first quality hire at AS2 Bio, he’s building systems, shaping culture, qualifying vendors, and laying the groundwork for clinical success.

He talks about the following:

🎙️ Moving from large pharma to lean biotech

🎙️ How to stand out in startup interviews

🎙️ Why AS2Bio hired quality *before* going to clinic

🎙️ How to prioritise when you’re the first quality hire

🎙️ What founders get wrong about consultants

🎙️ Cultural priorities when embedding quality early

🎙️ Building brand value to attract talent in Boston

🎙️ The mindset needed to thrive in ambiguity

🎙️ His player-coach leadership style

🎙️ His advice to aspiring quality leaders

Scott is a thoughtful, experienced and humble leader - someone who blends strategy, scientific rigor, and people-first leadership to help biotech companies move fast without cutting corners.

Thank you Scott for sharing your incredible journey.

Hope everyone enjoys the show!

In today's episode, we are joined by Stephanie Martin, Director of QA and Product Quality Lead at Adaptimmune.

Stephanie's journey into quality leadership is anything but traditional. She started out as a nuclear engineer at a shipyard before pivoting into biotech and building a career in quality.

What stands out is how she has faced bias around her age and appearance head-on, and still accelerated into leadership roles by focusing on EQ, credibility, and consistent performance.

Stephanie's story is a brilliant case study in how you can lead without waiting to be told you're ready.

We talk about the following:

🎙️Starting her career in a shipyard as a nuclear engineer.

🎙️Developing emotional intelligence in an industrial setting.

🎙️Transitioning into biotech and discovering her passion for quality.

🎙️Why a Director saw leadership potential in her before she did.

🎙️How she learned to influence without direct authority.

🎙️Overcoming bias around age, appearance, and experience.

🎙️Building credibility and scaling her impact at TCR² and Adaptimmune.

🎙️The mindset shift from tactical to strategic decision-making.

🎙️Her approach to hiring and coaching future quality leaders.

🎙️The advice she’d give to other young leaders looking to make their mark.

Stephanie is a thoughtful, driven, and emotionally intelligent leader who’s helping shape the future of quality in cell and gene therapy.

Thank you Stephanie for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode, I was joined by Megan Callan, Vice President of Quality at Abeona Therapeutics.

I really wanted to speak to Megan because her last few years at Abeona have been a masterclass in building a quality organisation that can handle the demands of commercial manufacturing - all while driving a digital transformation and keeping a patient-first mindset.

Megan has a unique career journey, moving across different industries and company sizes, and in this conversation, she opens up about how she’s navigated the shift from tactical to strategic leadership, what it takes to scale a quality team rapidly, and how AI is already influencing the role of QA.

We talk about the following:

🎙️ Megan’s early career moves and how she found her way into quality

🎙️ Leading Abeona’s scale-up from early clinical to commercial readiness

🎙️ Growing a QA team from 5 to 60+ people in a short timeframe

🎙️ The shift in mindset from tactical execution to strategic leadership

🎙️ Lessons learned from a major digital transformation project

🎙️ How to align quality with business objectives and patient needs

🎙️ Building resilience and navigating change at pace

🎙️ The role AI and IT now play in quality operations

🎙️ Advice for aspiring quality leaders who want to step into senior roles

Megan is a thoughtful and forward-thinking quality leader whose approach blends business acumen, strategic foresight, and a deep commitment to patient outcomes.

Thank you, Megan, for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode I was joined by Nolan Polson, Vice President of Quality Assurance and Product Quality at Iovance Biotherapeutics.

I really wanted to speak to Nolan because he’s one of the few leaders who’s built quality teams at every stage – from biologics at Amgen to radiopharma at Janssen, to launching two first-in-class cell therapies at Juno/Celgene/BMS.

Nolan’s career path is a great example of what it looks like to carry foundational quality principles into fast-paced, high-growth settings. He talks about his early scientific passion, how he transitioned from R&D to Quality Ops, and the leadership mindset required to scale from clinical to commercial.

We talk about the following:

• How Nolan's scientific roots in chemistry shaped his quality mindset
• Transitioning from R&D into Quality Ops and building speed with structure
• What Big Pharma taught him about good science, mature systems, and agency collaboration
• Scaling product quality teams from 2 to 45 during two cell therapy launches
• Building empowered leadership teams and the traits he looks for when hiring
• How AI can help quality teams move toward review-by-exception and proactive oversight
• The difference between biologics and cell therapy mindsets in a commercial setting
• Creating a culture of continuous learning and succession planning
• Lessons from moving across Amgen, J&J, GSK, BMS, and Iovance
• Why autologous cell therapy still holds massive curative potential

Nolan is a thoughtful, experienced quality leader who blends deep scientific expertise with a calm, strategic leadership approach.

Thank you Nolan for sharing your incredible journey.

Hope everyone enjoys the show!