Quality & Regulatory Affairs Manager - Trans Med

City of Hope   •  

Duarte, CA

Industry: Business Services


5 - 7 years

Posted 273 days ago

This job is no longer available.

Position Summary:

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

Essential Functions:

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)

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.
  • Takes appropriate actions related to error/accident/eventinvestigation, 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, reviewsand 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.
  • Facilitates appropriate change management activities within the division in response to new and/or revised regulatory or accrediting agency requirements.
  • 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.


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

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.

Position Qualifications:

Minimum Education:

  • Bachelor of Science degree

Minimum Experience:

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

Required Courses/Training:

Req. Certification/Licensure:

  • California license as a Clinical Laboratory Scientist or Immunohematology limited license;

Preferred Education:


Preferred Courses/Training:

  • CAP/AABB inspector

Pref. Certification/Licensure:

  • Specialist in Blood Banking (SBB)/(or equivalent)


  • Auditor and inspector skills; Able to use and apply statistical tools and techniques


  • SafeTrace Tx, Epic Beaker, MS Office applications (Word, Excel, PowerPoint, Access, Visio) and Adobe Acrobat Pro


  • Personal computer approximately 70 % of the time.

Working/Environmental Conditions:

Physical Demands:

  • Office setting with frequent walking to the various areas in transfusion medicine and other areas.