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!