White Coat: The Future of Quality Systems

Dawn Thut, CMQ/OE, CABP

Dawn Thut, CMQ/OE (ASQ), CABP, oversees the performance of the quality systems for the Cleveland Cord Blood Center, including the evaluation of testing procedures for product qualification and aseptic processing under cGMP guidelines. Her responsibilities include regulatory reporting and compliance, audits, design and review validations, incident and deviation investigations, risk assessments and determining appropriate corrective and preventative actions.

With more than 12 years of clinical laboratory experience, she understands the complexity of working with a biologic and the importance of quality, safety and efficacy in the final product. Thut holds a bachelor of applied science in medical technology from Youngstown State University, is an ASQ Certified Manager of Quality/Organizational Excellence, a Certified Advanced Biotherapies Professional and has a Regulatory Affairs Certificate for Pharmaceuticals from the Regulatory Affairs Professionals Society. She currently serves as a Team Leader for the AABB Cord Blood Subsection and is a member of the AABB Cord Blood Committee.

Thut spoke with AABB News about her career path, the evolution of quality systems and the future of cord blood and biotherapies.

AABB NEWS: How did you become interested in quality and regulatory affairs, and what led you to your current role at the Cleveland Cord Blood Center?

Thut: I’ve always appreciated structure and the role that regulations play in keeping people safe. Earlier in my career, I worked in a clinical laboratory that tested for cancer. I often felt a deep connection to the patients behind those samples.

When the Cleveland Cord Blood Center was founded in 2008, I was excited to help build its quality foundation from the ground up. My role started in the laboratory, and because the field of cord blood banking is highly specialized, I learned by doing. Together, we built the quality systems and processes. That experience taught me how to interpret regulations, understand what is necessary and why and appreciate the value of collaboration in shaping something truly impactful.

It felt meaningful to move from diagnosing disease to supporting a potential life-saving treatment and to be part of hope for patients and their families. I feel proud every time a product is released knowing the work behind it may ultimately help someone in need.

AABB NEWS: Why is quality such a critical part of cord blood banking and biotherapies?

Thut: Quality is central to cord blood banking and biotherapies because everything we do ultimately affects a patient’s safety and outcome. I always imagine that patient as myself or someone I love, and that perspective keeps me focused on maintaining the highest standards.

A strong quality program ensures every step, from collection to distribution, is controlled and consistent so that the final product is safe, effective and ready to offer real hope to someone in need. When patients may have limited treatment options, there is no room for compromise.

AABB NEWS: How has your clinical laboratory background influenced your approach to quality and regulatory oversight?

Thut: My experience on the bench helps me understand how critical accurate and reliable results are to patient care and successful outcomes. I know firsthand why quality control and equipment maintenance are essential and that having skilled staff in place is key to detecting potential issues during manufacturing.

I also have a deep appreciation for the collection team. Their role in educating donors and ensuring proper sample collection, labeling and handling is vital to the integrity of the final product.

That experience helps me evaluate processes not only from a compliance standpoint but also from an operational and patient-care perspective.

AABB NEWS: What is one misconception people have about quality or regulatory affairs?

Thut: One common misconception is that quality and regulatory affairs are all about policing or pointing out mistakes. In reality, our role is to build systems and processes that make it possible to produce safe, consistent products.

We rely on thorough documentation and continuous data monitoring to identify opportunities for improvement. When issues arise, we focus on understanding why they happened and implementing corrective and preventive actions – not assigning blame.

Creating a culture where quality is understood and supported across the organization is what truly drives success.

AABB NEWS: What changes do you see shaping quality systems as biotherapies continue to evolve?

Thut: As biotherapies continue to advance, quality systems are evolving in exciting ways. The traditional one-size-fits-all approach no longer works, especially with personalized treatments such as cell and gene therapies, so we’re seeing systems become more flexible and adaptive.

Data is increasingly driving decisions in real time. Tools such as artificial intelligence and automation can help identify trends, predict potential issues and maintain consistency across complex processes.

The future of quality systems is dynamic, data-rich and patient-centered. It’s about keeping pace with innovation while never losing sight of safety and reliability.

Regulators are also moving toward risk-based, lifecycle approaches, which means quality teams must think proactively rather than reactively. At the same time, global supply chains and cryogenic logistics have made traceability and transparency more important than ever.

Perhaps the biggest shift is cultural. Quality isn’t just a department anymore— it’s becoming part of how organizations think and operate every day, embedded in every decision and every process.

The future of quality systems is dynamic, data-rich and patient-centered. It’s about keeping pace with innovation while never losing sight of safety and reliability.

AABB NEWS: What do you enjoy most about volunteering with AABB and serving as Team Leader for the Cord Blood Subsection?

Thut: What I enjoy most about volunteering with AABB is the people. The members are incredibly welcoming and bring a wealth of experience and expertise. They’re generous with their time and knowledge, and I learn something new in every interaction.

AABB has also given me the opportunity to connect with professionals from around the world, and hearing their perspectives is always rewarding.

When I first joined the Cord Blood Subsection calls, I mostly listened. The leaders and attendees created such an open and collaborative environment that it encouraged me to grow more confident and begin contributing. Now, as a team leader, I try to foster that same culture—one where everyone feels comfortable speaking up and sharing ideas. We all have something valuable to contribute.

AABB NEWS: What advice would you give to someone interested in pursuing a career in quality and regulatory affairs?

Thut: Go for it! Explore the different paths within quality and regulatory affairs. There’s something for everyone. Whether your strengths are in science, data, problem-solving, technical writing or communication, this field offers opportunities to make a real impact on patient safety and product integrity.

Be curious and keep learning. Regulations and technologies are always evolving, so adaptability and a willingness to ask questions are key. Seek mentors who can share their experiences and help you see how quality connects every part of an organization.

Most importantly, remember that quality isn’t just about compliance. It’s about people. Every procedure, every document and every decision ultimately supports someone’s health and well-being. That sense of purpose makes this career incredibly rewarding.

Most importantly, remember that quality isn’t just about compliance. It’s about people. Every procedure, every document and every decision ultimately supports someone’s health and well-being. That sense of purpose makes this career incredibly rewarding.

AABB NEWS: What is your proudest professional accomplishment to date?

Thut: I’m incredibly proud to have been part of the Cleveland Cord Blood Center since its very beginning. Helping build the organization from the ground up has been one of the most rewarding experiences of my career.

As a small, independent public cord blood bank, we’ve accomplished so much. We have earned multiple accreditations, secured our Biologics License Application in 2016 and distributed more than 850 cord blood products to patients around the world.

What makes me proudest isn’t just the milestones themselves, but the teamwork and dedication behind them. Watching our mission grow from an idea into a trusted, lifesaving resource has been amazing. It’s a privilege to know that the work we do every day contributes to hope and healing for so many families.

Contributing to all of this in such a specialized field has been especially meaningful. Building systems and processes from the ground up taught me resilience, creativity and the value of collaboration in shaping something truly impactful.

AABB NEWS: What excites you most about the future of cord blood and biotherapies?

Thut: The possibilities are what excite me most about the future of cord blood and biotherapies. We’re only beginning to understand the full potential of these therapies—from regenerative medicine to immune modulation and beyond. Every new discovery opens doors to treating conditions that were once thought to be untreatable.

I’m inspired by how science, technology and collaboration are coming together to make these therapies more accessible and effective. The idea that a single cord blood unit that was once discarded medical waste could help save or improve someone’s life never stops being amazing.

As research expands, so does the hope we can offer to patients and families around the world.

AABB NEWS: At the end of a long day, how do you unwind?

Thut: At the end of a long day, I try to carve out a little time to unwind. I work full time and am the primary caregiver for my elderly mother, so life stays busy.

In the summer months, I love getting outdoors. Playing a round of golf or spending a weekend camping helps me reset and recharge. When that’s not possible, I escape into fictional audiobooks during my commute. It’s a simple way to relax, let my mind wander for a bit and recharge before diving back into everything that needs my attention.