Our team members are recognized leaders in the field — at Dana-Farber, throughout the region, and nationwide — with specialized expertise in cellular therapy quality (improvement, assurance, and control). In addition, our team members are experts in regulatory
compliance topics unique to this field, including cellular therapy clinical trials, and novel cellular manufacturing regulations.
Quality Assurance/Quality Improvement Specialist for Pediatrics and the Division of Stem Cell Transplantation and Cellular Therapies
Kimberly focuses on quality assurance and quality control for the Pediatric Stem Cell Transplantation program and the Division of Stem Cell Transplantation and Cellular Therapies. She focuses on ensuring system integrity for the pediatric patient and
donor case management system and performing clinical audits and other regulatory assessments for the pediatric program. Kimberly oversees the donor search process for pediatric patients and ensures donor services compliance with the tri-annual Foundation
for the Accreditation of Cellular Therapy (FACT) and other regulatory requirements.
Kristie DeFalco, MS
Quality Manager, Division of Stem Cell Transplantation and Cellular Therapies
Kristie is a Quality Manager for the Division of Stem Cell Transplantation and Cellular Therapies and is responsible for system integrity across operational components. She focuses on managing transplant workflow processes, monitoring cellular therapy data system integrity, systems interfaces, establishing cell therapies patient cases in the medical record system, case management data analysis and reporting. Kristie also ensures case management software validation, implementation, and maintenance. She assists with routine quality assurance audits, the tri-annual Foundation for the Accreditation of Cellular Therapy (FACT) inspections, and maintaining and tracking various program logs according to the strict requirements of outside regulatory agencies.
Mary Ann Kelley, MT(ASCP)BB
Quality Assurance Associate Director, Connell and O'Reilly Families Cell Manipulation Core Facility
Mary Ann provides the Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) with direction and leadership in the development and implementation of quality programs to support regulatory and accreditation requirements. She is responsible for the oversight of quality measures for the Stem Cell Processing Laboratory, Novel Cell Therapy Laboratory, and Cellular Therapy Testing Laboratory. She also oversees policies and procedures for product testing and release; ensures that all processes have been approved and validated; and oversees departmental audits and assessments to ensure regulatory compliance. She is an integral member of the Administrative team in providing guidance and oversight to the quality processes related to the development of relationships with Principal Investigators and company related trials.
Quality Assurance Manager, Immune Effector Cell Program, and Donor Services for the Division of Stem Cell Transplantation and Cellular Therapies
Bethany is responsible for quality management for the cellular therapy donor services program, immune effector cell therapy program, and the marrow collection facility. This includes management of the tri-annual Foundation for the Accreditation of Cellular Therapy (FACT) accreditation for those areas, National Marrow Donor Program (NMDP) quality assurance, performance metrics and analytics, standard operating procedures, deviation and corrective and preventative action (CAPA) management, and training and competency. She oversees the auditing and validation of marrow harvest procedures and the outcomes reporting for immune effector cell therapy and works closely with the processing lab and apheresis facility to monitor ongoing product quality.
Deborah Liney, MBA, CHTC
Quality Assurance Manager for the Division of Stem Cell Transplantation and Cellular Therapies
Deborah specializes in quality management for stem cell transplant patients. She manages standard-of-care treatment plans, working with faculty and staff in writing SOPs and consents. Deborah conducts clinical audits to meet regulatory requirements and financial coding compliance. She also works with clinicians on quality improvement projects. Deborah also manages the Cord Blood Donation Program based at Brigham and Women’s Hospital (BWH), as well as the stem cell transplant outcomes reporting team. As a division quality manager, Deborah collaborates with other quality and operations staff to maintain quality standards and readiness for the tri-annual Foundation for the Accreditation of Cellular Therapy (FACT) accreditation and other regulatory requirements.
Catherine Wright, MS
Quality Assurance/Quality Improvement Specialist and Document Control for the Division of Stem Cell Transplantation and Cellular Therapies
Catherine is responsible for content, maintenance, and continuing validation of the electronic document system, MasterControl, providing user support and ensuring all issues are reported and resolved with the vendor in a timely manner. She provides user access to the system and ensures all end users know where to find controlled documents and are continuously compliant with standard operating procedure (SOP) training. She collaborates with quality management and other staff to ensure Foundation for the Accreditation of Cellular Therapy (FACT) readiness and re-accreditation with a focus on document control. Catherine also assists with clinical and other documentation audits, documentation of deviations, and document creation.