What 2026 holds for biotech and Quality - with Jon Voss and Ed Armstrong

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!

Tämä jakso on lisätty Podme-palveluun avoimen RSS-syötteen kautta eikä se ole Podmen omaa tuotantoa. Siksi jakso saattaa sisältää mainontaa.

Jaksot(84)

Maja Pedersen on AI, Strategic Leadership, and Evolving as a Quality Leader

Maja Pedersen says following a process is what she does least, and she built a career in Quality because a clear framework gives people room to make pragmatic decisions.Maja Pedersen on AI, Strategic ...

6 Loka 50min

Colleen Walson-Billin on Building a Quality Career Without a Science Degree

Colleen Walson-Billin was told she was not eligible to progress in Quality without a science degree, and went on to lead a full GxP Quality function at a biologics startup.Colleen Walson-Billin on bui...

29 Syys 41min

Geetu Abbi on When to Build a Digital Quality Function

Geetu Abbi was handed the GAMP guide as a new validation engineer at Genzyme, and in 2024 she co-led one.Geetu Abbi on When to Build a Digital Quality FunctionIn today's episode I was joined by Geetu ...

22 Syys 41min

Isha Patel on the Overnight Career Plan That Took Her from Associate Director to SVP

Naymisha (Isha) Patel has spent thirty years in Quality and regulatory compliance across pharmaceuticals, biologics, medical devices and combination products. She is now Senior Vice President of Quali...

11 Syys 36min

Dawn Houlihan on Her Journey From Ireland Big Pharma to the Boston Start-Up World

Dawn Houlihan started out as the person manufacturing teams went quiet around, and spent the next twenty years proving that quality works better as a partner than a police force.Dawn Houlihan on Her J...

1 Syys 39min

Luciana Mansolelli on Her First Year as CQO in the CDMO World

Luciana Mansolelli spent twenty years on the sponsor side. One question from a board chairman moved her to a CDMO.Luciana Mansolelli on her first year as CQO in the CDMO world.In today’s episode I was...

25 Elo 39min

My Thoughts on Quality Leadership, Halfway Through Season Four

Season Four is at its halfway point, so instead of a guest this week I’ve gone back over the conversations so far and pulled out the theme that came up most often.The quality leader whose main functio...

30 Heinä 16min

Speaking the Language of the Business, with Jamey Lindholm

Quality culture isn't built by SOPs. It's built in the small moments when a leader reinforces the right behaviour or lets the wrong one slide.Speaking the Language of the Business, with Jamey Lindholm...

21 Heinä 38min