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Tuula Rintala
Director, Quality of Care and Advocacy
EBMT, European Society for Blood and Marrow Transplantation
Barcelona, Spain


In the evolving field of hematopoietic stem cell transplantation (HSCT) and cellular therapies, one role has quietly become indispensable: the Quality Manager.

As the regulatory and operational environment becomes more complex, dedicated quality professionals and dedicated quality management resources are central to safe, effective, and high-quality care. More than just compliance officers, Quality Managers lead system-wide improvements in quality assurance, risk management, incident reporting, training, and integration of fast-evolving regulations like the EU SoHO Regulation and Advanced Therapy Medicinal Products framework.

The FACT-JACIE Standards (from the Foundation for the Accreditation of Cellular Therapy and the Joint Accreditation Committee ISCT-Europe & EBMT) provide comprehensive quality and operational guidelines for hematopoietic cell therapy programs, including clinical, collection, and processing facilities. The key concepts of a Quality Management System (QMS) under the FACT-JACIE Standards are designed specifically for cellular therapy and transplantation services and are aligned with international quality principles while addressing the unique requirements of the field. Implementation of FACT-JACIE Standards have embedded concepts such as Quality Management Plan (QMP), Document and Process Control, Risk Management and Outcome Analysis as standard practices in certified Facilities.

Scientific data based on the EBMT registry data confirm that patients treated in JACIE-certified centres experience significantly improved relapse-free and overall survival (1, 2). JACIE certification has also been shown to improve the management of related donors (3). These outcomes correlate with the presence of robust quality management systems, managed and overseen by experienced Quality professionals. 

Quality managers play a critical role in cellular therapy programmes. Given the complexity and sensitivity of these processes, quality managers are essential in establishing and maintaining robust quality management systems (QMS) that ensure each step complies with Good Manufacturing Practice (GMP), Good Tissue Practice (GTP), and other relevant regulatory frameworks.

A central responsibility of quality managers is to oversee the development and implementation of standard operating procedures (SOPs) that govern all aspects of cellular therapy production. Their vigilance ensures that any potential risks to patient, staff or product safety are identified and mitigated early. Moreover, quality managers maintain documentation systems that ensure traceability of cell products from donor to recipient.

Quality managers also serve as key liaisons between clinical, laboratory, and regulatory teams. They help translate complex regulatory guidelines into practical, operational processes, and support staff training to ensure all personnel understand and adhere to quality standards. In rapidly evolving fields like cellular therapy, where innovation often outpaces regulation, quality managers play a pivotal role in adapting processes to new technologies while maintaining compliance and patient safety. Ultimately, their work underpins the credibility, reliability, and therapeutic success of cellular therapy programmes. 

It is because of this that JACIE has published a position statement in support of quality managers. Healthcare systems across Europe are under pressure and it is easy to see quality managers as ‘optional extras’ or ‘nice to have’. Without dedicated, specialist and protected quality manager resource, quality management system working becomes an afterthought and soon disappears from business-as-usual activity, patient (and staff) safety is compromised, and a culture of continuous improvement is lost. Working together, and acknowledging our specialist skills in science as well in quality management, we build strong and safer and more agile services to meet all and any challenges ahead.

Position statement available online: https://www.ebmt.org/ebmt/news/jacie-position-statement-critical-role-quality-managers

References

1. Gratwohl A, Brand R, McGrath E, van Biezen A, Sureda A, Ljungman P, Baldomero H, Chabannon C, Apperley J; Joint Accreditation Committee (JACIE) of the International Society for Cellular Therapy and the European Group for Blood and Marrow Transplantation, and the European Leukemia Net. Use of the quality management system "JACIE" and outcome after hematopoietic stem cell transplantation. Haematologica. 2014 May;99(5):908-15. doi: 10.3324/haematol.2013.096461. Epub 2014 Jan 31. PMID: 24488562; PMCID: PMC4008105. 
2. Gratwohl A, Brand R, Niederwieser D, Baldomero H, Chabannon C, Cornelissen J, de Witte T, Ljungman P, McDonald F, McGrath E, Passweg J, Peters C, Rocha V, Slaper-Cortenbach I, Sureda A, Tichelli A, Apperley J. Introduction of a quality management system and outcome after hematopoietic stem-cell transplantation. J Clin Oncol. 2011 May 20;29(15):1980-6. doi: 10.1200/JCO.2010.30.4121. Epub 2011 Apr 11. PMID: 21483006. 
3. Chloe Anthias, Paul V. O'Donnell, Deidre M. Kiefer, Jean Yared, Maxim Norkin, Paolo Anderlini, Bipin N. Savani, Miguel A. Diaz, Menachem Bitan, Joerg P. Halter, Brent R. Logan, Galen E. Switzer, Michael A. Pulsipher, Dennis L. Confer, Bronwen E. Shaw, European Group for Blood and Marrow Transplantation Centers with FACTJACIE Accreditation Have Significantly Better Compliance with Related Donor Care Standards, Biology of Blood and Marrow Transplantation, Volume 22, Issue 3.