Manager, TCT Regulatory Quality Management OC

City of Hope

Irvine, CA

Job posting number: #7143566 (Ref:10021380)

Posted: May 4, 2023

Application Deadline: Open Until Filled

Job Description

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

Oversees the Quality Program for the Hematopoietic Transplant Program and Cellular Therapy Programs. Maintains current knowledge of FACT (Foundations for the Accreditation of Cellular Therapy), AABB (American Association of Blood Banks), and NMDP (National Marrow Donor Program), and accreditation standards including Federal and State Regulatory reporting and licensing requirements for cellular therapy programs. 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 Program and Cellular Therapy Programs. Scope of responsibility crosses multiple Departments, in support of the City of Hope Hematology/HCT Department's joint pediatric-adult Oncology Hematopoietic Cell Transplant Program and Cellular Therapy Programs. 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 and Cellular Therapy Programs.

Key Responsibilities include:

Compliance and Regulatory Affairs

  • Assumes primary 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.
  • Oversees all review, interpretation, 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
  • Over sees preparation, review, approval, and implementation of HCT Quality Management policy and procedures ensuring procedures are in compliance with FACT Standards and all applicable state and government laws and regulations.
  • Over sees completion of error/accident/event investigations, tracking, reporting, and follow-up as applicable.
  • Over sees Completion of 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 (FACT Standard) and Regulatory requirements.

Licensing and Accreditation of the Hematopoietic Cell Program

  • Serve as the primary contact and liaison with all applicable external regulatory and accrediting agencies. Prepare for, coordinate, host, and follow-up on all inspections and provide reports and requested information

Quality Management/Quality Improvement

  • Develop, maintain, and administer the HCT Quality Management Plan /Program with the HCT Program Director, associate directors and /or designees.
  • Co-Chairs the COH HCT Quality Management Council and sub-committees, provides agenda and meeting support. Documents HCT 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 HCT program as required by accrediting agencies and in concert with the goals of the program.
  • Oversees the performance of quality audits and other ongoing assessments; develop annual quality initiatives and coordinates activities to achieve program goals.
  • Identifies and prioritizes opportunities for the HCT Program and the department's quality improvement work to be recognized nationally.
  • Consults with stakeholders in the development of HCT performance measures for specific Standard Operating Procedures or overall program measures
  • Oversees 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 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 HCT Program Director and associate directors as well as administrative leadership of HCT services at COH, regarding deviations from standard operating procedure, including impact on quality, resources, and/or cost of care, and recommendations for correction
  • Prioritizes and directs action on issues that need improvement, while identifying the current systems that are barriers to improving. Facilitates the development of HCT-related clinical pathways to standardize care and resource utilization.
  • Assists with HCT 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 HCT services QI team and members of the multi-disciplinary HCT Quality management program to monitor quality and develop improvement strategies.
  • Uses available technology to enhance documentation, track outcomes and communicate with other care providers.

Management

  • Hires, trains and directs and evaluates activities of HCT Regulatory and Quality Specialist(s) to ensure program integrity. 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:

  • Bachelor's degree in nursing or other healthcare related field.
  • Content expert in quality improvement concepts plus minimum of 5-7 years of nursing and/or health care leadership experience.
  • One to 2 years 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.

Preferred education experience and skills:

  • Master Degree
  • Clinical Hematology and cellular therapy, Transfusion medicine services.

Preferred Courses/Training:
CPHQ (Certified Professional in Healthcare Quality

  • Preferred Certification/Licensure:
    Registered Nurse highly preferred or may have alternative experience managing a TCT program
  • CPHQ (Certified Professional in Healthcare Quality

Additional Information:

  • The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
  • As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

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.

Salary / Pay Rate Information:
Pay Rate: $53.19 - $88.82 / hour

The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.



City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.


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