Senior TCT Regulatory & Quality Management Specialist

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

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 and control 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 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 under the direction of 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.

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 re-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.
• 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).
• 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.
• 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.

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned or requested.

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.
• PreferablyMaster's Degree in Nursing or in related/complementary field. CPHQ (Certified Professional in Heath care Quality), CPHM (Certified Professional in Healthcare Management), Medical technologist ASCP or equivalent as applicable

Additional Information:

• To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.