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!