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Let's Talk Quality

Hemish Ilangaratne
Quality Assurance
Biotechnology
Pharmaceutical Industry
Leadership
Cell Therapy
Career Development
Gene Therapy
Quality Leadership
Patient Safety
Regulatory Affairs
Biotech Industry
Leadership Development
Clinical Trials
Cell and Gene Therapy
Quality Control
Compliance
Pharmaceuticals
Drug Development
Car-T Cell Therapy
Mentorship

“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 ... more

PublishesWeeklyEpisodes77Founded3 years ago
Number of ListenersCategories
CareersScienceBusinessLife Sciences

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Artwork for Let's Talk Quality

Latest Episodes

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.

In today's episode I was joined by Jamey Lind... more

YouTube

Twenty years at Merck, then a leap into academia and psychedelic medicine - here is how Dawn Lundin built a quality career on instinct.

Dawn Lundin on the big pharma habits you have to unlearn in a startup.

In today's episode I was joined by Dawn L... more

YouTube

Forty seven years in quality, and Tim Mitchell says the job he started is nothing like the one he does today.

Tim Mitchell on how quality stopped being black and white

In today's episode I was joined by Tim Mitchell, Vice President of Quality at Ak... more

YouTube

What does it really take to build a quality organization from the ground up - and do it again, and again, across multiple companies? Laura Singer on building quality that scales.

In today's episode I was joined by Laura Singer, Vice President of Qua... more

YouTube

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Recent Guests

Jamey Lindholm
Head of Quality at R1 Therapeutics; former Biogen and Seres Therapeutics quality leader
R1 Therapeutics
Episode: Speaking the Language of the Business, with Jamey Lindholm
Dawn Lundin
Founder, Lundin Consulting Group; quality leader with extensive Merck background
Episode: The Big Pharma Habits You Have to Unlearn in a Startup, with Dawn Lundin
Tim Mitchell
Vice President of Quality
Aktis Oncology
Episode: How Quality Stopped Being Black and White, with Tim Mitchell
Laura Singer
Quality executive with broad GXP leadership experience
Loyal (vet drug company)
Episode: Building Quality That Scales, with Laura Singer
Jake Trees
Quality leader with extensive background in biopharmaceuticals and cell therapy, formerly Celgene/BMS
Celgene/Bristol Myers Squibb
Episode: Three BLAs, Three Journeys, with Irving Ford, Megan Callan, and Jake Treese
Cinta Burgos
Senior Vice President of Quality and Regulatory CMC
New Amsterdam Pharma
Episode: The Non-Linear Path to Quality Leadership, with Cinta Burgos
Mike Ruane
Head of quality at Bristol Myers Squibb for in vivo CAR T
Bristol Myers Squibb
Episode: From the Graveyard Shift to the Frontier of Cell Therapy, with Mike Ruane
Laurie Adami
Cancer survivor, patient advocate, memoir author
Episode: Laurie Adami on Life After CAR-T, and the Reality Patients Still Face
Burak Begen
Head of Global Manufacturing Quality, Siemens Healthineers
Siemens Healthineers
Episode: How to Drive KPI's the Right Way in Global Quality, with Burak Begen

Hosts

Laura Singer
Quality executive with broad GXP leadership experience; host of the show
Hamish
Host of the podcast; conducts interviews with patients and industry experts

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Talking Points

Recent interactions between the hosts and their guests.

Speaking the Language of the Business, with Jamey Lindholm
Q: How do you translate quality into the language of business to gain executive buy-in?
By framing quality in terms of risk, regulatory complexity, inspection readiness, and potential impacts on the bottom line, and by providing concrete solutions and clear asks, you show how quality protects patients and enables faster, safer progress.
Speaking the Language of the Business, with Jamey Lindholm
Q: When is the right time to bring in a permanent head of quality in a biotech startup?
There isn't a one-size-fits-all answer, but embedding quality in the leadership from the very beginning enables faster, more durable infrastructure and decisions, reducing the need to retrofit later and increasing the odds of successful development and inspections.
Speaking the Language of the Business, with Jamey Lindholm
Q: What prompted you to move from Biogen to Seres, and how did that shift shape your perspective on quality leadership?
Moving from a large, established company to a startup exposed me to end-to-end quality leadership and the need to build infrastructure from scratch, which broadened my view of how quality intersects with every function and how I must translate compliance into business value for the company's success and patient impact.
How Quality Stopped Being Black and White, with Tim Mitchell
Q: What key advice would you give to someone starting their quality leadership journey in 2026 and beyond?
Recognize that you are working for a business and learn to balance compliance with progress; seek diverse experiences across manufacturing, regulatory, and clinical QA, and cultivate mentorship relationships to grow leadership capability and the ability to communicate with regulators and investors.
How Quality Stopped Being Black and White, with Tim Mitchell
Q: From a quality lens, how would you sell quality to an aspiring quality professional?
Quality should be framed as a collaborative, value-adding function that helps the team document and communicate decisions clearly, adapt to evolving technologies, and enable products to move from development to commercialization safely and efficiently.

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Frequently Asked Questions About Let's Talk Quality

What is Let's Talk Quality about and what kind of topics does it cover?

This series centers on quality leadership in life sciences, with a strong emphasis on scaling quality systems, regulatory readiness, and the people-side of quality. Episodes frequently explore how to build robust, scalable quality infrastructures across biotech, cell therapy, and pharma, including handling inspections, recalls, and FDA interactions, while balancing speed, patient safety, and regulatory compliance. Guests are often senior quality leaders or executives who share practical leadership lessons, cross-functional collaboration strategies, and narratives from early-stage startups to commercial-scale operations. A standout trait is the focus on culture, mentorship, and developing the next generation of quality professionals, along w... more

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1. Morning Brew Daily
2. Search Engine
3. The Daily

How many episodes of Let's Talk Quality are there?

Let's Talk Quality launched 3 years ago and published 77 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Let's Talk Quality?

Recent guests on Let's Talk Quality include:

1. Jamey Lindholm
2. Dawn Lundin
3. Tim Mitchell
4. Laura Singer
5. Jake Trees
6. Cinta Burgos
7. Mike Ruane
8. Laurie Adami

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