In Conversation with Robert D. Marriott: Bridging Blood Banking and Biotherapies

The most successful organizations in the future will be those that use quality as an enabler of innovation, helping bring new therapies to patients safely, efficiently and at scale.”

This month’s “In Conversation” column features Robert D. Marriott, executive vice president and chief quality officer at Vitalant, where he oversees the organization’s quality management, regulatory and compliance programs across blood services, biotherapies and clinical testing.

Marriott joined Vitalant in 2024 as vice president of clinical and research quality services with more than 30 years of experience across blood services, clinical testing, biopharma and medical device industries. Promoted to chief quality officer in 2026, Marriott leads Vitalant’s enterprise-wide quality management system, quality and regulatory compliance programs, supporting the delivery of safe, reliable blood and cellular products, transfusion medicine, and clinical testing services for the patients and communities Vitalant serves. He holds a bachelor’s degree in biochemistry from the University of Detroit Mercy, as well as certification and training in quality and compliance auditing and continuous improvement methods.

Marriott spoke to AABB News about the evolving role of quality, lessons shared between blood banking and biotherapies and preparing organizations for the future of advanced therapies.

As biotherapies continue to evolve, how do you see quality systems evolving to support these new therapies while maintaining the same commitment to patient safety?

The mission of quality does not change. Our responsibility remains to protect donors, patients, product quality and public trust. What is changing is the complexity of these therapies and the speed of innovation. Quality systems are evolving from primarily compliance-focused programs to more predictive, risk-based, and digitally enabled systems that support innovation while maintaining safety.

I expect greater use of electronic batch records, advanced analytics, automation and AI-assisted risk monitoring. At the same time, quality must move upstream in the process, helping design robust controls, validate new technologies and assess risk early rather than simply reviewing outcomes after the fact.

You have worked under quality and regulatory frameworks across several areas of health care. From your perspective, where are the quality systems used in blood banking and biotherapies most closely aligned?

Quality systems are fundamentally built around the same principles: donor and patient safety, traceability, process control, training, documentation, deviation management and continuous improvement. Whether supporting blood components, cellular therapies or other biologic products, quality systems exist to ensure that safe, effective products reach patients consistently.

The strongest commonality is a culture of discipline. Success in both fields depends on doing thousands of small things correctly every day and maintaining rigorous control over processes that directly affect patient outcomes.

Where do you see the greatest differences between traditional blood banking quality programs and those supporting biotherapies? What can the blood banking and biotherapies fields learn from one another?

The biggest difference is the maturity and standardization of the manufacturing model. Blood banking has spent decades developing highly standardized manufacturing processes supported by validated technologies and extensive use of closed-system processing. Those closed systems have been instrumental in reducing contamination risk, improving consistency, decreasing deviations and allowing blood products to be manufactured efficiently at scale.

Many cellular therapy processes are still relatively immature by comparison. Open and semi-open manipulations, extensive operator intervention, cleanroom dependence and customized workflows contribute to higher costs, greater variability and increased manufacturing risk. One of the most important opportunities for the cellular therapy industry is accelerating the adoption of automation and closed-system manufacturing technologies. Doing so will help lower costs, reduce manufacturing failures, decrease waste and improve patient access.

There are also important differences in quality organization structure. Blood centers often rely on highly capable quality generalists who oversee multiple quality system elements. As biotherapies mature, organizations frequently add specialized disciplines such as manufacturing QA, quality engineering, supplier quality, computerized systems validation, microbiology and environmental monitoring. Those functions become increasingly important as manufacturing complexity grows.

Blood banking can learn from biotherapies' advances in automation, analytics and advanced manufacturing science. Biotherapies can learn from blood banking's decades of experience in traceability, operational scale, process standardization and closed-system manufacturing.

As blood centers continue expanding into cellular therapies and other biotherapies, what are the biggest quality and regulatory challenges organizations face, and how can they prepare for what's ahead?

One challenge is understanding and navigating increasingly complex regulatory frameworks. Organizations may find themselves operating across blood regulations, tissue regulations, biologics requirements and GMP expectations, sometimes simultaneously.

A second challenge is building the necessary infrastructure and expertise before complexity outpaces capability. Validation, data integrity, supplier quality, computerized systems, cleanroom operations and advanced quality oversight all become more important as organizations move deeper into biotherapies.

AABB members that succeed will invest in quality systems, governance and talent development early rather than waiting until growth creates compliance or operational challenges.

How do you see the role of quality evolving as blood centers become more involved in biotherapies?

Quality is increasingly becoming a strategic partner in organizational growth rather than simply a compliance function. The future role of quality is to enable responsible innovation while protecting safety, compliance and public trust.

I often describe this evolution as moving from quality as compliance, to quality as risk management, to quality as a strategic enabler. Quality organizations will increasingly help shape technology adoption, operational readiness, risk assessments and regulatory strategy for emerging therapies.

Many professionals entering biotherapies today come from traditional transfusion medicine backgrounds. What aspects of blood banking prepare them well for work in biotherapies, and what new skills are becoming increasingly important as they transition into the biotherapies space?

Blood banking professionals bring a strong foundation in regulated operations, donor and patient safety, quality systems, traceability, deviation management and process control. These skills translate exceptionally well into biotherapies.

The new skills becoming increasingly important include cleanroom operations, process validation, computerized system validation, electronic batch records, supplier quality, advanced analytics and emerging manufacturing technologies.

Just as important is a mindset of continuous learning. Science and technology are evolving rapidly, and curiosity will be an essential leadership and professional skill for success. This mindset is a hallmark of the professionals that work in the blood banking community.

Innovation in areas such as artificial intelligence is transforming health care. How do you see these technologies influencing quality management and regulatory compliance in blood banking and biotherapies over the next decade?

I believe AI's greatest impact will be in predictive quality management. Quality organizations generate enormous amounts of operational and compliance data, and AI can help identify emerging risks, detect trends earlier and prioritize areas requiring attention.

AI will also likely improve document management, investigations, regulatory intelligence, training effectiveness and audit readiness. However, AI cannot replace human judgment. Independent quality decision-making, scientific expertise and accountability will remain essential, but will be enhanced with better data and research enabled by AI tools. The greatest value will come from combining strong quality systems with advanced analytical tools guiding expert human decision making.

Looking ahead, what emerging trends in quality management are you most excited about, and how do you think they will shape the future of blood and biotherapies?

The most exciting trend is the shift from reactive quality to predictive quality. Historically, quality systems focused on identifying issues after they occurred. Increasingly, digital tools, analytics, automation and AI are allowing us to identify and mitigate risks much earlier.

I am also excited by the continued movement toward automation, closed-system manufacturing, digital quality platforms and standardized manufacturing approaches. These advances have the potential to improve quality, reduce cost, increase manufacturing reliability and expand patient access to advanced therapies.

Most importantly, we are seeing a growing recognition that quality and innovation are not competing priorities. The most successful organizations in the future will be those that use quality as an enabler of innovation, helping bring new therapies to patients safely, efficiently and at scale.