About City of Hope

City of Hope is an independent biomedical research and treatment organization for cancer, diabetes and other life-threatening diseases.

Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope’s specialized cancer expertise.

A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.

City of Hope’s commitment to Diversity, Equity and Inclusion

We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds and perspectives; this is reflected in our work and represented in our people.

Position Summary

As a central subject matter expert in the area of TCT Regulatory and Quality Management, the Senior TCT Regulatory Quality Management Specialist performs a variety of advanced work in the area of Quality Management, including risk identification, assessment and response. This position is fully versed in Quality Management techniques and regulatory and accreditation requirements for Donor and Recipient of Hematopoietic Cell Transplant and cellular therapy including use of immune effector cells. The Senior TCT Regulatory/Quality Specialist works autonomously and under the guidance of the Director, Risk, Quality & Safety, in the areas of quality and regulatory monitoring, surveillance, consultation, policy development, research, and education. Additionally, incumbents in this position will assist to orient and train newly-hired TCT Quality Specialists and provide direction and work review of other TCT Quality Specialists, working in partnership with the TCT Quality/Regulatory Manager. The Senior Specialist maintains current knowledge of FACT (Foundations for the Accreditation of Cellular Therapy), AABB (American Association of Blood Banks), and NMDP (National Marrow Donor Program) Accreditation standards including Federal and State Regulatory reporting and licensing requirements for cellular therapy programs. Also acting as a change agent to lead, facilitate and support the improvement of clinical and service quality for the City of Hope Hematopoietic Cell Transplantation and Cellular Therapy Program. Scope of responsibility crosses multiple Departments, in support of the City of Hope Hematology/TCT Department's joint pediatric-adult Oncology Hematopoietic Cell Transplant Program. Includes consultation for program leaders and staff, development of performance measures, education, root cause analysis, statistical process control and use of quality improvement tools. Acts as facilitator for achievement of key Quality Initiatives and objectives which are integral to the success of the Hematopoietic Cell Transplantation and Cellular Therapy Program.

Key Responsibilities include:

Compliance and regulatory affairs

• Assumes responsibility to assure cross-organizational compliance with Foundation for the Accreditation of Cellular Therapy (FACT) accreditation standards and preparation for accreditation surveys and other regulatory requirements.
• Leads the reviews, interprets, and assesses the application of new, and revised regulations, standards, guidelines, etc. from regulatory and accrediting agencies for the Hematopoietic Cell Program including Blood and Marrow Transplant and Cellular Therapies under the guidance and supervision of the TCT Regulatory /Quality Manager.
• Facilitates preparation, review, approval, and implementation of TCT Quality Management program policy and procedures ensuring they are in compliance with FACT Standards and all applicable state and government laws and regulations.
• Completes error/accident/event investigations, tracking, reporting, and follow-up as applicable.
• Completes procedural validation audits and review of all equipment, process, and system validation including the EMR processes applicable to hematopoietic and cellular therapy.
• Attends ongoing education and training related to the field of cellular therapy and quality management in accordance with FACT standards and regulatory or certification requirements.
• Serves as a liaison with operations and others, including vendor quality representatives for REMS program and other reporting requirements for cellular therapies assuring compliance with Federal guidelines and requirements.
• Leads reviews, and assesses the application of new processes impacting risk and safety of hematopoietic and cellular therapy donors and recipients, and analytic programs utilized for Data collection and auditing.

Licensing and Accreditation of the Hematopoietic Cell Program

• Serve as a secondary contact and liaison with all applicable external regulatory and accrediting agencies. Lead the preparation/coordination, and follow-up on all inspections under the guidance and supervision of the TCT Quality Manager and provide reports and requested information.

Quality Management

• Assists in the Development, maintenance, and administration of the TCT Quality Management Plan /Program with the TCT Program Director, associate directors and /or designees, and TCT Regulatory Quality Manager.
• Assists the TCT Regulatory Quality Manager and Chair of the COH TCT Quality Management Council and sub-committees, provides agenda and meeting support. Documents TCT Quality Management Council activities and provides reports to institutional quality committees and ad hoc committees.
• Coordinates the development, monitoring and reporting of quality improvement processes and quality controls for the TCT program as required by accrediting agencies and in concert with the goals of the program.
• Performs quality audits and other ongoing assessments; assists in the development of annual quality initiatives and coordinates activities to achieve program goals.
• Identifies opportunities for the TCT Program and the department's quality improvement work to be recognized nationally.
• Assists with training and education of TCT Regulatory & Quality Management Specialist(s).
• Consults with stakeholders in the development of TCT performance measures for specific Standard Operating Procedures or overall program measures
• Assists in the oversight of TCT Policy and procedure development, review and revision documentation processes and compliance to key operating procedures.
• Provide assistance and coverage as needed to the manager and senior leadership of the department.
• Acts as a resource for hospital and medical staff performance improvement. Consults with identified hospital or medical staff to understand the TCT Quality Management Program requirements, QI process, their relationship to FACT Accreditation requirements, and in general to improve care and services.
• Analyzes and stratifies data, identifies trends and uses quality improvement theory for interpreting statistical variation and control, acting on findings and formulating plans for continued evaluation/improvement.
• Provides reports to the TCT Program Director and associate directors as well as administrative leadership of TCT services at COH, regarding deviations from standard operating procedure, including impact on quality, resources, and/or cost of care, and recommendations for correction.
• Under the guidance of manager, takes action on issues that need improvement, while identifying any current systems that are barriers to improvement. Facilitates the development of TCT-related clinical pathways to standardize care and resource utilization.
• Assists with TCT Program education activities for department and medical staff and assists the director in developing educational plans for the department around performance improvement.
• Provides “just-in-time” and formal education related to improving quality. Serves as an internal resource for PDSA, FMEA and other improvement methodologies. Works closely with TCT services QI team and members of the multi-disciplinary TCT Quality management program to monitor quality and develop improvement strategies.
• Uses available technology to enhance documentation, track outcomes and communicate with other care providers.
• Administrative support personnel in the scheduling of meetings, policy and procedure documentation and upload, forms revisions, data collection and preparation of reports to accreditation agencies.

Basic education, experience and skills required for consideration:

• BSN or BS/BA in related/complementary field required.
• Experience may substitute for minimum education requirements.
• A background in a related field such as medical technology, blood banking, clinical informatics or quality management with appropriate experience may substitute for the education requirement with VP approval.

• An ideal candidate will have experience in Clinical Hematology/Hematopoietic Cellular Therapy, Transfusion medicine services, or solid organ transplant program.
• Fully versed in Quality Management techniques and regulatory and accreditation requirements for Donor and recipient of cellular therapy and Hematopoietic Cell Transplant including use of immune effector cells.
• Content expert in quality improvement concepts plus minimum of 5-7 years of nursing and/or health care leadership experience.
• 2-4 year of quality improvement experience, to include consultation or direct work in process improvement or rapid cycle improvement, systems thinking concepts, team facilitation, performance measurement and/or stratification of data.

Required Courses/Training:

• Content expert in quality improvement concepts, ongoing education and training related to the field of cellular therapy and quality management (FACT standards, NMDP Standards, and CIBMTR requirements)

Preferred education experience and skills:

• Experience in an accredited Hematopoietic Cellular Therapy/Transplant Program or solid organ transplant program.
• Database development or experience

Preferred Courses/Training:

• Quality Management related courses

Preferred Certification/Licensure:

• CPHQ (Certified Professional in Heath care Quality), CPHM (Certified Professional in Healthcare Management), Medical technologist ASCP or equivalent as applicable
• Preferred Registered Nurse Licensure

Additional Information:

• As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.