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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

PublishesWeeklyEpisodes74Founded3 years ago
Number of ListenersCategories
Life SciencesBusinessScienceCareers

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Artwork for Let's Talk Quality

Latest Episodes

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

From the lab bench to the C-Suite - and every crisis in between.

In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics.

I really wanted to speak to Kim because her career ... more

YouTube

Three BLAs. Three companies. One industry-defining challenge.

Jake Trees, Irving Ford, and Megan Callan on What It Really Takes to Cross the Commercial Line in Cell and Gene Therapy

In this special compiled episode of Let's Talk Quality, Hemish Ila... more

The non-linear path is often the most powerful one.

Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets.

In today's episode I was joined by Cinta Burgos, Senior Vice President of Quality and Regulatory CMC at New Amsterdam ... more

YouTube

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Recent Guests

Laura Singer
Quality executive with broad GXP leadership experience
Loyal (vet drug company)
Episode: Building Quality That Scales, with Laura Singer
Irving Ford
Executive (quality leadership) discussing leading Adaptimmune through FDA approval and commercialization of T cell therapy
Adaptimmune
Episode: Three BLAs, Three Journeys, with Irving Ford, Megan Callan, and Jake Treese
Megan Callan
Vice President of Quality at Abeona Therapeutics
Abeona Therapeutics
Episode: Three BLAs, Three Journeys, with Irving Ford, Megan Callan, and Jake Treese
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
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
Melodie Bryce
Chief Quality Officer for Kincell Bio
Kincell Bio
Episode: Developing Future A-Player Quality Leaders, with Melodie Bryce
Rex Ready
Head of quality at Bebio (Bbio)
Bbebio/Bebio
Episode: Lessons from Building Quality in Start-Up Cell Therapy, with Rex Ready

Hosts

Hamish
Host of the podcast
Hemish Alangaratney
Co-host and longtime host of Let's Talk Quality

Chart Rankings

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

Talking Points

Recent interactions between the hosts and their guests.

Building Quality That Scales, with Laura Singer
Q: How should quality leaders interact with the CEO or executive team to be effective?
Presence and accessibility matter; the leader should bring clear guidance, a plan, confidence, and the ability to translate regulatory expectations into actionable steps for the organization.
Building Quality That Scales, with Laura Singer
Q: What are the key traits you look for when hiring in quality roles?
Self-starters with strong communication, cultural fit, and the ability to collaborate under pressure; the ability to stay calm and trusted when issues arise; and a propensity to empower others.
Building Quality That Scales, with Laura Singer
Q: How do you approach scaling quality systems when moving from a systems-focused role to a broader GXP leadership position?
She describes starting with alignment to business goals, performing gap assessments, and building scalable processes that can handle higher volumes while staying compliant, then slowly stepping into leadership by demonstrating capability and delivering on plan.
The Non-Linear Path to Quality Leadership, with Cinta Burgos
Q: How do you view AI in regulated industries like biotech and pharma?
AI has promise for data visualization and trend analysis, but it requires human oversight, guardrails, and validation of data inputs to avoid artifacts; use AI to augment, not replace, critical regulatory decisions.
From the Graveyard Shift to the Frontier of Cell Therapy, with Mike Ruane
Q: What early career decisions set you up for later opportunities?
He emphasizes embracing diverse roles within the same organization through mergers and acquisitions, and taking on new programs (like CAR-T) even when unfamiliar, as long as you build a solid quality foundation and problem-solving mindset.

Audience Metrics

Listeners, social reach, demographics and more for this podcast.

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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?

The show centers quality leadership in life sciences, with episodes featuring senior quality executives, regulators, and transformation leaders. Across conversations, listeners get practical strategies for building and sustaining quality cultures in startups and large organizations, implementing digital tools and AI in regulated environments, and aligning quality with patient safety, regulatory expectations, and business goals. Guests frequently discuss leadership development, cross-functional collaboration, inspection readiness, and scaling quality systems in biotech, cell therapy, and pharma, often with a focus on startup growth, regulatory readiness, and modernizing quality through technology. A notable strength is bringing real-world, b... more

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Which podcasts are similar to Let's Talk Quality?

These podcasts share a similar audience with Let's Talk Quality:

1. Hidden Brain
2. Morning Brew Daily
3. Good Hang with Amy Poehler
4. Radiolab

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

Let's Talk Quality launched 3 years ago and published 74 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. Laura Singer
2. Irving Ford
3. Megan Callan
4. Jake Trees
5. Cinta Burgos
6. Mike Ruane
7. Burak Begen
8. Melodie Bryce

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