“Let’s Talk Quality” is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries to share their knowledge, experiences, and strategies for achieving quality excellence. Join us on a journey of discovery as we unravel the importance of quality and its profound impact on businesses and society. Get ready to engage in insightful discussions, gain valuable perspectives, and unlock the secrets to fostering a culture of quality in every aspect of life. Tune in and let’s embark on this exciting quality-driven adventure together.
In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences, and the importance o…
Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and opportunities that come w…
In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech.
Andrea shares her career journey and insights into quality leadership. She started in biotech manufacturin…
In today's episode, we're joined by Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics.
Gary shares that his love for reading and learning, as well as his curiosity abo…
In today's episode I was joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit.
Regeneron are launching a new cell therapy unit after the acquisition of …
In today's episode I'm joined by Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing.
Laurie (as she is known as to those close to her) recently relocated from Miami to Michi…
In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics.
I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all …
Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder cancer.
Kelly shares he…
In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK.
Marcus, shares his journey …
Today I spoke with Sonia Razzetti, SVP of Quality at Disc Medicine, a clinical stage biotech focussed on developing therapies in the haematology space. Sonia shares her journey in quality and discuss…
We are back for Season Two of Lets Talk Quality!
This week, I had the pleasure of speaking with Irving Ford, VP of Quality at Adaptimmune Therapeutics.
Irving has been through the commercialisation o…
Joe Franchetti, President of the Society of Quality Assurance (SQA), shares his vision for the SQA and the wider quality assurance industry, emphasizing the importance of collaboration and expanding …
This is very special episode. I was joined by Laurie Adami, a financial services exec who was forced to give up her career after a cancer diagnosis in 2006.
After a 12 year battle fighting follicular…
In this conversation, Kimberly Wallbank, a quality systems consultant in the pharma & biotech industry, shares her insights and experiences in the world of contracting. She discusses the changes in t…
This week I speak with Stan Russell, who explains how quality leaders can create a function that adds true value to an organisation.
Stan provides practical advice for leaders to change perceptions an…
This week I was joined by Vaishali Shukla, VP of Global Quality Manufacturing at Kite Pharma.
"Act locally but think globally”. This is the mindset that Vaishali has helped instil in her role to help …
As a biotech professional, how do you know that the questions you ask 'experts' are accurate?
Is the answer based on explicit regulations? Or is it based on personal opinion, which has been formed by …
This is a story about the journey of commercialization for BMS' first cell therapies approved for the treatment of blood cancer.
Jason 'Jake' Treese, played a critical role in the development, approva…
This week on the podcast I speak with Emily English, VP of Quality at Cartesian Therapeutics.
Cartesian is a clinical-stage biopharmaceutical company developing RNA cell therapies designed to benefit …
The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade.
Several examples of poor data integrity practises have demonstrated the consequences it…