JACIE Position Statement: The Critical Role of Quality Managers

Why Quality Managers matter more than ever in cellular therapies?

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.

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 donors³. These outcomes correlate with the presence of robust quality management systems, managed and overseen by experienced Quality professionals. 

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 haves’ . 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.

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.