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 Aktis Oncology, a radiopharmaceutical company in Boston developing treatments across several types of cancer. I really wanted to speak to Tim because very few people have watched quality evolve the way he has. He started in 1980, when the GMP regulations were barely a year and a half old and a quality assurance function did not really exist yet.

Tim's story begins in a loud, industrial antibiotic fermentation plant, monitoring sixty to ninety thousand gallon fermenters that ran into the ground. His father worked in the neighbouring department at Eli Lilly, and an internship near his hometown turned into fourteen years at Lilly and a career that carried him from big pharma through to the start-up world he works in now. Along the way he moved from manufacturing into a validation team, without knowing what validation even was, and found that quality suited him.

What comes through most is his view of the role itself. Tim does not see quality as a police force. He sees it as a collaborative partner to the rest of the business, a role that demands technical depth, patience and judgement. He talks openly about how the work has moved from black and white rule-following to something far more gray, especially in early-stage biotech where the science is moving faster than the rulebook.

We talk about the following:

• How the quality function grew from a paperwork desk job into a value-adding partnership
• Why some of the best quality people come from manufacturing backgrounds
• The case for learning proper GMP systems in big pharma before joining a start-up
• What good mentoring actually looks like, and why annual reviews are not enough
• How the relationship between the FDA and biotech is becoming genuinely collaborative

Tim Mitchell is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Tim for sharing your incredible journey. Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR

• Quality professionals moving from big pharma into a clinical-stage biotech
• Managers building or scaling a quality management system from scratch
• Manufacturing and technical operations people considering a move into quality
• VPs and Directors of Quality thinking about how they mentor their teams
• Anyone early in their quality career trying to understand where the role is heading

Timestamps:

(00:00) Introduction to Tim Mitchell and His Journey

(02:27) Evolution of Quality in the Pharmaceutical Industry

(05:07) The Changing Landscape of Quality Roles

(07:59) Skills for Modern Quality Professionals

(10:29) Mentorship and Team Development

(13:16) The Future of Quality Leadership

(16:20) Navigating the Transition from R&D to Commercialization

(19:01) The Role of Quality in Biotech Innovation

(21:12) Challenges and Opportunities in Quality Management

(24:38) The Importance of Collaboration in Quality

(27:07) Advice for Aspiring Quality Leaders

She came to the US with her first year's tuition and figured the rest out from there. What followed is one of the most grounded quality leadership journeys I have heard - and one we felt was worth bringing back.

Swetha Krishnan on Building a Quality Mindset from the Ground Up

This is a rerelease of one of our favourite episodes from two years ago. In today's episode I was joined by Swetha Krishnan. I really wanted to bring this conversation back because Swetha's route into quality was entirely unplanned - and the way she has turned that unplanned start into a clear leadership philosophy is something every quality professional should hear.

Swetha came to the US from India to complete a master’s in bioengineering at the University of Toledo. She needed work, she needed a visa sponsor, and she found her way into a contractor role at Pfizer in Connecticut doing technical writing and validation. It was not the destination she had mapped out, but two years of being moved from role to role - quality management systems, regulatory content authoring, client-facing support - gave her a cross-functional view of how a pharma company actually operates. From there she moved through roles at Biogen, Sanofi Genzyme, and Alkermes before taking on her current position leading quality across all GXPs at Mural Oncology, a clinical-stage biotech focused on cytokine-based immunotherapies for cancer.

Swetha leads with a combination of strategic clarity and genuine warmth. She is honest about the things she struggled with early on - particularly the belief that credibility required having all the answers - and equally clear about what changed that. She talks about the boss at Alkermes who told her she would one day be head of quality before she believed it herself, the nine-month Women Unlimited LEAD program that gave her two external mentors, and the MIT Leadership

Signature course that asked her to examine what in her personal history shapes how she shows up every day.

We talk about the following:

• How a bioengineering thesis on non-invasive glucose measurement for diabetics led to an unexpected start in quality

• Starting as a contractor at Pfizer and what wearing so many hats in two years taught her about the whole product life cycle

• Why validation gave her a quality mindset before she had ever formally joined a quality team

• The shift from individual contributor to manager to leader of teams - and why it forced her to rethink everything she thought she knew about credibility

• The nine-month Women Unlimited LEAD program at Alkermes and the boss who saw her potential before she saw it herself

• Quality by design in practice - being involved in CRO selection from the start, not after the contract is signed

• How she manages prioritisation, managing up, and keeping her team grounded in a lean, fast-moving clinical-stage biotech

• Her 4C model for aspiring quality leaders: challenge, curiosity, collaboration, and compassion

Swetha is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. You can watch on LinkedIn Live at 12pm EST today or listen via Apple or Spotify. Thank you Swetha for sharing your incredible journey. Hope everyone enjoys the show.

Who This Episode Is For

• Quality managers and directors in clinical-stage biotech who are building systems and leading teams without large headcounts or unlimited budgets

• Aspiring heads of quality who are in the transition from individual contributor to people leader and finding that shift harder than they expected

• Quality professionals who came into the function from validation, technical writing, or another non-traditional route and are still making sense of how it all connects

• Senior quality leaders who want a practical framework for developing the next generation on their team

• Anyone in pharma or biotech who has ever felt like asking for help put their credibility at risk

Timestamps:

(00:00) Introduction to Swetha Krishnan and Mural Oncology

(05:08) The Importance of Quality in Biotech

(11:00) The Role of Quality in Driving Strategy

(16:39) Managing Stress and Prioritization

(21:55) Self-Development and Continuous Learning

(26:44) Advice for Aspiring Quality Leaders

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 Quality and Compliance at Loyal. I really wanted to speak to Laura because she has spent the better part of two decades walking into an early-stage biotech and building everything from scratch. Each time, a different product, a different regulatory landscape, a different team. And each time, the same fundamental challenge: how do you build quality infrastructure that is fit for today, but will not break tomorrow?

Laura's career is a study in what it means to grow as a quality leader. She started in quality systems, realized she wanted more breadth, and made a deliberate move into a full GXP leadership role at Amicus as VP of Quality - a company that was developing its first commercial product for a rare disease. She came in as a senior director, proved herself, and earned the VP title. From there she spent six years at Heron Therapeutics building out an international quality function, and has since continued that pattern in successive roles.

What makes Laura a compelling guest is not just the technical expertise - it is her philosophy. She talks about quality not as a compliance function, but as a business partner. She talks about leadership not as direction-giving, but as creating the conditions for other people to own their work. And she talks about the job of a quality head at the executive level with unusual clarity: you walk in with a plan, you are calm, you translate the regulations for the people around you, and you do not retreat when things go wrong.

We talk about the following:

• What it means to find your niche as a quality leader and how Laura discovered hers

• Making the leap from a specialist quality systems role to a full GxP VP position without a network inside the company

• How to communicate with a C-suite and executive team as a quality leader - and where most people get it wrong

• What actually breaks in a quality system when a company scales from 40 to 140 people

• How to define inspection readiness in practice, including the CDMO piece that often gets underestimated

• Leadership philosophy, hiring for fit, and the importance of executive presence in quality

Laura is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality

professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.

Thank you Laura for sharing your incredible journey. Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR

• Quality leaders at VP and SVP level who are navigating the transition from compliance-focused to business-aligned quality leadership

• Heads of Quality at early-stage biotechs who are building or scaling their quality function for the first time

• Senior Directors and Directors of Quality who are ready to make the step up to VP and want to understand what that leap really looks like

• Quality professionals at any level who want to build stronger relationships with their C-suite and executive team

• Anyone in the life sciences who wants to understand what good quality leadership actually looks like in practice

Timestamps:

(00:00) Introduction to Laura Singer's Career Journey

(05:47) Navigating Organizational Challenges

(08:55) Effective Communication with Executives

(12:06) Scaling Quality Systems in Organizations

(17:34) Leadership Philosophy and Team Building

(20:47) Managing Upwards and Sideways

(24:26) Future Aspirations and Career Advice