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

Plans, coordinates, and leads all areas of the Division of Transfusion Medicine in activities related to quality, and compliance/regulatory affairs.

Provides oversight and leadership of all quality management activities carried out in all areas of transfusion medicine. Provides guidance to the division in regards to meeting the requirements of regulatory and accrediting agencies for patient and donor testing, therapeutic apheresis, blood product manufacturing, and cellular therapy product manufacturing. Demonstrates a level of working knowledge of the following agencies (as appropriate):

• Food and Drug Administration (FDA)
• California Department of Public Health (CDPH)
• Center for Medicare and Medicaid Services (CMS).
• Joint Commission (JC)
• AABB (formerly American Association of Blood Banks)
• College of American Pathologists (CAP)
• Foundation for Accreditation of Cellular Therapy (FACT)
• National Marrow Donor Program (NMDP)/Be The Match (BTM)

Key Responsibilities include:

Compliance and Regulatory Affairs

• Provides a review, interpretation, and assessment of the effect of all new, and revised regulations, standards, guidelines, etc. from regulatory and accrediting agencies on transfusion medicine operations.
• Reviews and approves of all operational policies and procedures in transfusion medicine in collaboration with quality colleagues, operational directors in transfusion medicine, medical directors and pathology quality and compliance director.
• Reviews Quality Agreements and contracts for stem cell products (commercial and clinical research).
• Takes appropriate actions related to error/accident/event investigation, tracking, reporting, and follow-up.
• Reviews and approves of all equipment, process, and system validation activities.
• Assists areas with the development of validation plans and documents appropriate for the process/equipment being validated, and provides assistance with data analysis, as needed.
• Provides reports to external regulatory/accrediting agencies as required.

Quality Management

• Maintains, reviews and modifies the transfusion medicine quality management program as needed
• Leads the transfusion medicine division’s QA committee and serves as a member of other institutional quality and ad hoc committees as designated by the Pathology Quality director.
• Performs quality audits and other ongoing assessments of operations, and work on performance improvement activities.
• Responds to second-party site visits and audits of stem cell collection and processing (commercial and clinical research).
• Facilitates appropriate change management activities within the division in response to new and/or revised regulatory or accrediting agency requirements.
• Participates in interdisciplinary teams on process improvement.
• Maintains an adequate understanding and working knowledge of principles and techniques used in blood and cellular therapy product collection and processing in order to apply quality management practices to these activities.

Licensing and Accreditation

• Serves as a transfusion medicine primary contact and liaison with all external regulatory and accrediting agencies.
• Maintains appropriate licenses and certifications required for blood and cell therapy manufacturing.
• Assists in preparing, coordinating and following up on all inspections and provides reports and requested information for all agencies.

Financial

• Assists management with budget planning, contracting, and ongoing expense monitoring.

Information Systems

• Collaborates with transfusion medicine information systems staff on the evaluation, proper use of, and development of transfusion medicine information systems.
• Monitors the proper integration of transfusion medicine information systems with laboratory and hospital information systems.

Basic education, experience and skills required for consideration:

• Bachelor of Science degree
• 5 years of experience in Blood Banking and blood/cell therapy manufacturing (or equivalent regulated medical manufacturing environment)

Required Certification/Licensure:

• California license as a Clinical Laboratory Scientist or Immunohematology limited license; or will obtain either California license within 6 months from date of hire.

Additional Information:

• 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. #LI-AH