Let's Talk Quality13 Aug 2025

Megan Callan on Leading Quality at Abeona to it’s First FDA-Approved Therapy

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!

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