Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.

Works under the direction of the TCT Quality/Regulatory Manager. 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 including Hematopoietic Cell Transplant and immune effector cells. Also acts 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 Program.

As a successful candidate, you will:

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 re-accreditation surveys and other regulatory requirements.
• Reviews, interprets, and assesses the application of all 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.
• Facilitates preparation, review, approval, and implementation of TCT Quality Management program policy and procedures ensuring they are compliant 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 activities applicable to hematopoietic 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.

Licensing and Accreditation of the Hematopoietic Cell Program

• Serve as the 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
• 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.
• 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.
• 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
• Acts 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.

Your qualifications should include:

Minimum Education:

• 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.

Minimum Experience:

• An ideal candidate will have experience in Clinical Hematology/Hematopoietic Cellular Therapy, Transfusion medicine services, or solid organ transplant program.
• Content expert in quality improvement concepts plus minimum of 2-4 years of nursing and/or health care leadership experience.
• 1-2 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)

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.