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Senior Manager Quality & Regulatory Affairs Transfusion Medicine more...
Location:Duarte, CA
Company:City of Hope
First posted:March 28, 2017 (last updated 2 days 22 hours ago)

Job Requisition: # 9472

Job Title: Senior Manager, Quality and Regulatory Affairs - Transfusion Medicine Administration

Position Summary:

Plan, direct, coordinate, and lead all areas of the Division of Transfusion Medicine in activities related to quality, and compliance/regulatory affairs, and oversee activities involving the evaluation, implementation, use, and ongoing development of transfusion medicine information systems.

Essential Functions:

Planning, budgeting, and staff development and oversight for the Transfusion Medicine Administration (aka: Compliance) section.  Oversight and leadership of all quality management activities carried out in all areas of transfusion medicine.  Leadership and resource for compliance and regulatory affairs activities in all areas, especially in manufacturing of blood and cell therapy products.  Due to the broad operational scope, this position involves direct contact and varied relationships on multiple departmental and organizational levels, utilizing professional leadership, and promoting interdisciplinary collaboration and cooperation.

Provide leadership and direction 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.  Requirements of the following agencies apply (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

  • Review, interpret, and assess application to our operations all new, and revised regulations, standards, guidelines, etc. from regulatory and accrediting agencies

  • Review and approve of all operational policies and procedures in transfusion medicine

  • Error/accident/event investigation, tracking, reporting, and follow-up

  • Review and approve of all equipment, process, system validation activities.  Assist areas with the development of validation plans and documents appropriate for the process/equipment being validated, and provide assistance with data analysis, as needed

Quality Management

  • Responsible for the development , maintenance and administration of the transfusion medicine quality management program

  • Serve as chair of the division QA committee and as a member of other institutional quality and ad hoc committees as needed.

  • Perform quality audits and other ongoing assessments of operations, and work on performance improvement activities.

  • Facilitate appropriate change management activities within the division in response to new and/or revised regulatory or accrediting agency requirements.

Licensing and Accreditation

  • Serve as the primary contact and liaison with all external regulatory and accrediting agencies.

  • Maintain appropriate licenses and certifications required for blood and cell therapy manufacturing.

  • Prepare for, coordinate, host, and follow-up on all inspections and provide reports and requested information for all agencies.

Financial and Personnel Management

  • Assist with budget planning, contracting, and ongoing expense monitoring and reporting for the compliance cost center operations and transfusion medicine information systems.

  • Oversee and develop a team of qualified and competent staff to carry out quality activities and to administer and control information systems.

Information Systems

  • Oversee and work with transfusion medicine information systems staff on the evaluation, proper use of, and development of transfusion medicine information systems.

  • Work with transfusion medicine staff on the proper integration of transfusion medicine information systems with laboratory and hospital information systems.

Position Qualifications:

  • Bachelor of Science degree
  • 5+ years of experience in Blood Banking and blood/cell therapy manufacturing (or equivalent regulated medical manufacturing environment).
  • California license as a Clinical Laboratory Scientist or Immunohematology limited license.

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

City of Hope strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced. City of Hope is 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-RA






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