Step inside the real journey to becoming a Qualified Person (QP) â the emotional highs, the setbacks, the VIVA pressure, and the diverse paths that lead to one of pharmaâs most respected roles. In this deep dive, we share real stories from QPs, assessors, and trainees â revealing what it actually takes to qualify, what makes candidates stand out, and why the QP role is far more than just technical knowledge. Whether youâre preparing for QP training, exploring a QA career, or fascinated by pharmaceutical quality, this episode will give you rare insights you wonât find in textbooks.-
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đDownload The QP Diaries: The Playbook
Learn from 21 Quality Leaders as they share their real-world experiences â from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs whoâve walked the same path â all in one powerful guide.
đ Download now: https://bit.ly/49zZ2F1
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How Strong Is Your Hiring Strategy?
Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. â˘Uncover hidden gaps slowing down your hiring â˘Benchmark your process against best-in-class recruitment practices â˘Get tailored, actionable recommendations you can use immediately
đStart your Recruitment Health Check!
https://bit.ly/4o37Tm9
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About AssureBio AssureBio unites the worldâs Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, weâre trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful â to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.
Contact us:
đ www.assure-bio.com
đ§ enquiries@assure-bio.com
The 3 Golden Threads: Lessons from 21 QPs is an exclusive 10-minute bonus for the early launch group. Drawn from years of conversations, it explores resilience, leadership, and patient focus, the timeless lessons every QP needs. A glimpse of whatâs to come in The Playbook
Unlock the 3 Golden Threads shared by 21 Qualified Personsâpowerful insights that every aspiring or current QP, QA professional, and pharma leader should know. In this exclusive Deep Dive from QP Diaries: The Playbook, we break down what truly matters: resilience for the QP viva, authentic leadership, collaboration, and the unshakeable focus on patient safety.Whether you're preparing for your QP viva, planning your QP career path, or leading in pharmaceutical quality assurance, these lessons will transform how you grow, lead, and make critical quality decisions
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đDownload The QP Diaries: The Playbook
Learn from 21 Quality Leaders as they share their real-world experiences â from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs whoâve walked the same path â all in one powerful guide.
đ Download now: https://bit.ly/49zZ2F1
------------------
How Strong Is Your Hiring Strategy?
Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. â˘Uncover hidden gaps slowing down your hiring â˘Benchmark your process against best-in-class recruitment practices â˘Get tailored, actionable recommendations you can use immediately
đStart your Recruitment Health Check!
https://bit.ly/4o37Tm9
------------------
About AssureBio AssureBio unites the worldâs Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, weâre trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful â to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.
Contact us:
đ www.assure-bio.com
đ§ enquiries@assure-bio.com
Dive into the ultimate collection of QP wisdomâdistilled from 21 world-class Quality leaders across the pharmaceutical industry. Whether you're preparing for your QP Viva, navigating GMP compliance, building a quality culture, or stepping into pharma leadership, this video breaks down the most powerful lessons shared on The QP Diaries: The Playbook. Perfect for aspiring QPs, QA professionals, and anyone shaping patient-centric decisions in the Life Sciences.
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đDownload The QP Diaries: The Playbook
Learn from 21 Quality Leaders as they share their real-world experiences â from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs whoâve walked the same path â all in one powerful guide.
đ Download now: https://bit.ly/49zZ2F1------------------
How Strong Is Your Hiring Strategy?
Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. â˘Uncover hidden gaps slowing down your hiring â˘Benchmark your process against best-in-class recruitment practices â˘Get tailored, actionable recommendations you can use immediately
đStart your Recruitment Health Check!
https://bit.ly/4o37Tm9
------------------
About AssureBio AssureBio unites the worldâs Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, weâre trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful â to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.
Contact us:
đ www.assure-bio.com
đ§ enquiries@assure-bio.com
AI is reshaping pharmaceutical Quality Assurance faster than ever â from batch release to deviation investigations to QP training. In this deep-dive, we unpack insights from leading voices in pharma QA and QP development, exploring the real impact of AI, the new skills QPs must build, and the regulatory gaps the industry urgently needs to address. If you're a Qualified Person, QA Manager, Quality Leader, auditor, or aspiring QP, this is your shortcut to staying ahead of the biggest shift in GMP, compliance, and pharmaceutical manufacturing.
------------------
đDownload The QP Diaries: The Playbook
Learn from 21 Quality Leaders as they share their real-world experiences â from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs whoâve walked the same path â all in one powerful guide.
đ Download now: https://bit.ly/49zZ2F1------------------
How Strong Is Your Hiring Strategy?
Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. â˘Uncover hidden gaps slowing down your hiring â˘Benchmark your process against best-in-class recruitment practices â˘Get tailored, actionable recommendations you can use immediately
đStart your Recruitment Health Check!
https://bit.ly/4o37Tm9
------------------
About AssureBio AssureBio unites the worldâs Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, weâre trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful â to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.
Contact us:
đ www.assure-bio.com
đ§ enquiries@assure-bio.com
In this Deep Dive, we unpack the human side of pharmaceutical Quality Assurance â from building high-performing QA cultures to coaching future QPs, handling pressure, leading through change and preparing for AI-driven quality systems. Drawn from candid interviews with Qualified Persons (QPs) and senior QA leaders across the UK pharma industry, this episode delivers real-world insights on leadership, resilience, quality culture, GMP decision-making, coaching, and the future of the QP role. If youâre a Quality Director, Senior QA Leader, or aspiring QP, this is your essential playbook for leading people, shaping culture, and staying ahead of the industry's biggest changes.
------------------
đDownload The QP Diaries: The Playbook
Learn from 21 Quality Leaders as they share their real-world experiences â from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs whoâve walked the same path â all in one powerful guide.
đ Download now: https://bit.ly/49zZ2F1------------------
How Strong Is Your Hiring Strategy?
Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. â˘Uncover hidden gaps slowing down your hiring â˘Benchmark your process against best-in-class recruitment practices â˘Get tailored, actionable recommendations you can use immediately
đStart your Recruitment Health Check!
https://bit.ly/4o37Tm9
------------------
About AssureBio AssureBio unites the worldâs Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, weâre trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful â to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.
Contact us:
đ www.assure-bio.com
đ§ enquiries@assure-bio.com
This episode dives deep into how GMP pharmaceutical facilities are really built, featuring real stories and insights from Qualified Persons (QPs) and Quality leaders who have led new site builds, scale-ups, aseptic expansions, and MHRA inspections. If you work in QA, QC, Validation, ATMPs, sterile manufacturing, or are on the QP pathway, this is your shortcut to understanding the risks, pitfalls, timelines, culture challenges and inspection readiness strategies behind a successful GMP facility launch. Youâll learn about: ⢠QP leadership during GMP builds ⢠MHRA licensing mistakes to avoid ⢠Environmental monitoring, qualification, validation ⢠Post-licence optimisation realities ⢠QA culture, team building & tech adoption (LIMS, MES, AI) Perfect for aspiring QPs, QA professionals, and anyone preparing for GMP site builds, facility expansion, or MHRA inspection readiness.
------------------
đDownload The QP Diaries: The Playbook
Learn from 21 Quality Leaders as they share their real-world experiences â from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs whoâve walked the same path â all in one powerful guide.
đ Download now: https://bit.ly/49zZ2F1------------------
How Strong Is Your Hiring Strategy?
Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. â˘Uncover hidden gaps slowing down your hiring â˘Benchmark your process against best-in-class recruitment practices â˘Get tailored, actionable recommendations you can use immediately
đStart your Recruitment Health Check!
https://bit.ly/4o37Tm9
------------------
About AssureBio AssureBio unites the worldâs Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, weâre trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful â to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.
Contact us:
đ www.assure-bio.com
đ§ enquiries@assure-bio.com
Learn what really happens when a pharma quality crisis hits. In this QP Diaries deep-dive, we explore how Qualified Persons (QPs) lead GMP remediation, restore MHRA/FDA compliance, fix systemic quality failures, and rebuild a strong quality culture under extreme pressure. Featuring insights from leading QPs in the UK pharmaceutical industry, this episode breaks down the real triggers behind quality system breakdowns, regulatory findings, amber-light warnings, culture issues, CAPA failures, and what it takes to successfully steer a company through remediation.
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đDownload The QP Diaries: The Playbook
Learn from 21 Quality Leaders as they share their real-world experiences â from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs whoâve walked the same path â all in one powerful guide.
đ Download now: https://bit.ly/49zZ2F1------------------
How Strong Is Your Hiring Strategy?
Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. â˘Uncover hidden gaps slowing down your hiring â˘Benchmark your process against best-in-class recruitment practices â˘Get tailored, actionable recommendations you can use immediately
đStart your Recruitment Health Check!
https://bit.ly/4o37Tm9
------------------
About AssureBio AssureBio unites the worldâs Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, weâre trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful â to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.
Contact us:
đ www.assure-bio.com
đ§ enquiries@assure-bio.com
Discover the REALITY of becoming a Qualified Person (QP) â the training, the viva, the failures, the crises, and the leadership journey. This deep dive reveals true stories from AssureBioâs QP Diaries archive: batch release challenges, high-stakes decisions, QP mindset, resilience, quality culture, and how QPs evolve across decades. Whether you're an aspiring QP, a QA professional, or leading Quality teams in pharma, this episode breaks down: â How QPs get started â The gruelling QP training journey â Viva exam strategies â Real GMP crises (including site fires, deviations & million-pound batch rejections) â Leadership evolution for modern QPs â AI, ATMPs & the future of pharmaceutical Quality
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đDownload The QP Diaries: The Playbook
Learn from 21 Quality Leaders as they share their real-world experiences â from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs whoâve walked the same path â all in one powerful guide.
đ Download now: https://bit.ly/49zZ2F1------------------
How Strong Is Your Hiring Strategy?
Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. â˘Uncover hidden gaps slowing down your hiring â˘Benchmark your process against best-in-class recruitment practices â˘Get tailored, actionable recommendations you can use immediately
đStart your Recruitment Health Check!
https://bit.ly/4o37Tm9
------------------
About AssureBio AssureBio unites the worldâs Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, weâre trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful â to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.
Contact us:
đ www.assure-bio.com
đ§ enquiries@assure-bio.com
What happens when someone outside of QA gets the chance to step up as a Qualified Person? In this episode of The QP Diaries, we sit down with Graham Clarke, a seasoned pharmaceutical professional whose 20+ year journey spans sterile manufacturing, solid dosage forms, and cutting-edge cell and gene therapy. Graham shares his unexpected path into QA and how he seized the opportunity to become a QP at Baxterâdespite not coming from a traditional Quality background. He walks us through the realities of preparing for and sitting the VIVA, offering practical insight for Trainee QPs and those navigating their own journey. Now working as a QP Consultant, Graham candidly reflects on why he chose to go independent, the challenges heâs faced, and what heâs learned along the way. This episode is packed with real talk, hard-earned lessons, and a refreshing perspective on what it really takes to grow, adapt, and thrive as a QP in todayâs pharmaceutical landscape. Whether youâre just starting your journey or leading at the highest levels, this career-focused conversation will give you the insightâand the reassuranceâthat thereâs more than one path to a successful QP career.
In this episode of the QP Diaries, weâre joined by Adam Walker, the first NHS Qualified Person (QP) to appear on the podcast. Adam shares his personal journey to becoming a QP, how he tackled the VIVA (and what heâd do differently), and his pivotal role in leading development and innovation at the NENC Medicines Manufacturing Centre.
We dive into how the NHS is transforming aseptic services across the region, the future role of AI in Quality Assurance, and the skills QPs will need moving forward. Adam also lifts the lid on Help Me GMP, the YouTube channel he co-hosts with Kyle Winn, which is making GMP training more accessible, practical, and powerful.
you're a Trainee QP, experienced QA leader, or just curious about how NHS-led manufacturing is evolving, this episode is packed with insight, honesty, and forward-thinking.
In this episode of The QP Diaries, weâre joined by Stephen Clarke, newly appointed Head of Quality and Qualified Person at BDD. With decades of experience across diverse pharmaceutical environments and a proven track record leading global Quality functions, Stephen shares his unique journey, from his early days in food lab QC to becoming a QP responsible for complex clinical and commercial products. Stephen reflects on the formative years of his QP training, the value of cross-site exposure in sterile and OSD manufacturing, and the realities of batch certification in todayâs evolving regulatory landscape. Now at BDD, heâs leveraging his deep GMP expertise to support cutting-edge radiolabelled medicines and same-day QP release, accelerating clinical insights and patient access. We explore the growing responsibility of QPs in shaping Pharmaceutical Quality Systems (PQS), the impact of AI on decision-making, and why strong communication is critical when working in contract manufacturing. Stephen also shares how he mentors the next generation of Quality professionals and the one piece of advice heâd give to his younger self. Whether you're a trainee QP, Quality leader, or simply curious about the human side of pharmaceutical compliance, this episode is packed with practical insights and leadership perspective.
In this episode of The QP Diaries, weâre joined by Damian Larrington â an experienced and eligible Qualified Person under 2001/83/EC and 2001/20/EC, with a background spanning aseptic, biologic, ATMP, IMP, terminally sterilised, and solid dose products.
We explore Damianâs journey to becoming a QP, what it truly means to be âthe right personâ for the role, and how to balance study, work, and personal growth in a highly regulated environment. Damian shares practical insight on the importance of practicing difficult conversations, what QPs need to prepare for in an AI-driven global landscape, and the critical challenges facing todayâs pharmaceutical quality professionals.
Whether you're a trainee QP, seasoned professional, or just curious about the future of Quality, this episode is packed with perspective, honesty, and invaluable advice from one of the industryâs most grounded voices.
In this episode, Dal is joined by Marie, a distinguished Quality Professional whose career reflects decades of diverse experience across R&D, Regulatory Affairs, and Quality Assurance. From her early days as a QC Chemist to her most recent role as QP for sterile products, Marie shares candid reflections on embracing mistakes as powerful learning moments, staying open to new opportunities, and the discipline instilled through QP training. With experience spanning inhalation products, biologics, combination devices, and hosting inspections from global regulators like the FDA and HPRA, Marie brings a grounded yet inspiring perspective to professional growth. Whether you're at the beginning of your QP journey or navigating senior QA leadership, this episode offers valuable insights into resilience, continuous learning, and the mindset needed to thrive in pharma quality.
In this episode, Dal sits down with David Waddington, a true veteran of the pharmaceutical quality landscape, whose career spans over 30 years across global roles in QA, manufacturing, and regulatory compliance. From his first steps toward becoming a Qualified Person (QP) to leading international quality teams at major pharmaceutical organizations, Dave shares a career built on embracing opportunities, adapting to challenges, and mentoring the next generation of quality professionals. Now part of the team at NSF and formerly Quality Director, Global Regulatory Compliance at Catalent, Dave brings a wealth of insight into EU and FDA GMPs, auditing excellence, and international compliance. Whether you're an aspiring QP or a seasoned QA leader, this episode is packed with practical wisdom, candid reflections, and career-defining lessons.
What does it really take to become a Qualified Personâand feel confident in the role once you're there?In this episode of The QP Diaries, weâre joined by Vicky, an experienced Qualified Person, Quality professional, and NSF trainer with over 20 years in the pharmaceutical industry. Her career spans R&D, clinical trials, tech transfer, commercial manufacturing, and site closuresâgiving her a rare perspective on the full product lifecycle.Now supporting QP trainees through NSFâs training programme, Vicky shares practical advice and encouragement for those on the journey to becoming a QP.We discuss:The role of a QP in supporting and managing change within QA teams and operationsHow mind mapping can strengthen your VIVA preparationThe value of mock VIVA sessionsâand how to make them countThe key qualities and skills that help QPs succeed in the real worldWhether you're preparing for your VIVA, building your confidence, or just exploring what the QP role involves, this episode is full of insight and real-world advice from someone who trains and mentors future QPs every day.
With over 16 years of pharmaceutical experience, Uche Ekwuozor is a Chartered Chemist, Chartered Scientist, and Qualified Person (QP) renowned for his deep expertise in sterile products, biologicals, and GMP compliance. From leading MHRA remediation projects to overseeing global quality operations at top pharmaceutical firms like BMS/Celgene and MSD Animal Health, Uche brings a wealth of insight into Quality Risk Management, QMS integration, and regulatory strategy.In this episode, we dive into Uche's impressive journeyâfrom working across clinical and commercial manufacturing environments to becoming a key figure in shaping quality systems, coaching future QPs, and navigating complex audits and compliance challenges. A true advocate for operational excellence and continuous improvement, Uche shares valuable lessons and bold perspectives on what it takes to lead in pharmaceutical quality today.
Welcome to the QP Diaries podcast! In this episode, host Dal welcomes Catherine Kay from NSF, the new sponsor of the show. With over 20 years of experience in pharmaceutical operations management and technical QA, Catherine is also an eligible QP. Together, they explore the vital role of quality assurance in the pharmaceutical industry and the dedication required to become a Qualified Person (QP). Catherine also shares insights on people development and fostering learning organizations. Tune in for expert perspectives on the QP journey and the evolving landscape of pharmaceutical quality.
Key Moments:
[00:01:01] QP training and support.
[00:04:57] Quality assurance career transition.
[00:09:05] Career evolution and opportunities.
[00:11:14] Importance of investing in people.
[00:15:51] Employee investment benefits organizations.
[00:18:10] Essential qualities for QPs.
[00:25:03] Personal development and mentorship.
[00:26:33] Evolving role of a QP.
[00:31:25] Educating QPs of the future.
[00:33:52] Trainee QP symposium networking.
In this episode of the QP Diaries podcast, host Dal interviews Mark King, who has over 30 years of experience in Quality based roles within the pharmaceutical industry. Mark is a Qualified Person under the permanent provisions since March 2001, and a former QP Assessor, Vice Chair and Chair of the Royal Society of Biology QP Assessors Panel.During the episode, Mark shares insights from his career journey and offers valuable advice to QPs and trainees. This includes sharing his best tips with trainees preparing for their VIVA, as well as rare insights into his experience as a panel assessor. The discussion also delves into mergers and acquisitions and managing site closures from a QP's perspective, giving important guidance for anyone wishing to further their understanding of the pharmaceutical sector.
Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal interviews Ilona, a newly qualified QP in the UK pharmaceutical industry. Ilona shares her journey from a background in microbiology to becoming a QP, discussing her experience in quality control and R&D roles in clinical and pharmaceutical settings. Tune in to gain insights into Ilona's career transition and valuable expertise as a qualified person.
Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar interviews Rebecca, a seasoned quality assurance professional and qualified person (QP) in the UK pharmaceutical industry. They discuss various aspects of Rebecca's career, including her journey as a QP, her expertise, and her accomplishments. The episode focuses on leadership, team collaboration, tools and methodologies used in quality assurance, and advice for aspiring QPs. Listeners will gain insights into the world of quality assurance and learn from Rebecca's experiences as a leader in the industry. Tune in to this inspiring episode to empower your career in quality assurance.