The Quality and Accreditation Manager oversees quality assurance and regulatory compliance activities of the BMT and Cellular Therapy Program, including bone marrow collection, the Apheresis Unit, and inpatient and ambulatory clinical programs.

Under the joint direction of the Northwest Marrow Transplant Program Director, the Medical Director of the Adult Blood and Marrow Stem Cell Transplant and Cellular Therapy Program, and the Quality Medical Director of the Division of Hematology and Medical Oncology, the Quality and Accreditation Manager is responsible for planning, implementing, performing, maintaining, and evaluating all quality assurance and improvement activities under the scope of the position to ensure provision of the highest quality care to patients. The Quality and Accreditation Manager is responsible for regulatory and accreditation compliance including but not limited to DNV-GL, FACT, and FDA through the development, review and implementation of Standard Operating Procedures (SOPs), the development of Quality Management Plans, and other systems/processes to ensure compliance with the above organization’s standards. The incumbent will interpret regulatory regulation requirements in a way that efficiently supports and improves clinical care. The position requires meeting timely regulatory reporting requirements, ensuring adequate staff education, training and competency related to those standards, and maintaining up-to-date knowledge of all relevant standards, rules, and regulations.

Accreditation by FACT (Foundation for the Accreditation of Cellular Therapy) is a requirement of national, regional, and local insurance companies for inclusion in their transplant networks.

Quality Program Management:

• Establishes and maintains systems and procedures to monitor the quality of the areas under the scope of the position.
• Performs scheduled and unscheduled quality audits of processes, analyzes outcome, and process indicators for the clinical program and Apheresis Unit. Generates reports, reviews with leadership, management and other appropriate stakeholders, and makes recommendations based on results.
• Responsible for accreditation surveys and readiness.
• Ensures compliance with all applicable regulatory and accrediting agency requirements.
• Coordinates inspections by regulatory and accrediting agencies, prepares response to inspection reports, and ensures timely implementation of corrective measures.
• Communicates trends and opportunities for improvement to key process owners.
• Participates in the BMT Program Cross Functional Quality Committee and other Hematology Oncology and Apheresis Unit quality committees and workgroups as needed. Assists in preparation of agendas and minutes of meetings and ensures completion of meeting action items at the discretion of the Committee chairperson.
• Regularly compiles reports for presentations to quality committees.
• Performs a comprehensive quality audit annually of the BMT Program and Cellular Therapy Program, Apheresis Unit, and marrow collection services, and reports to program leadership on the overall performance of the  quality program.
• Prepares the NWMTP annual quality management plan reports for the BMT Program Cross Functional Quality Committee.
• Serves as liaison for the areas under the scope of this position to relevant quality committees.
• Collaborates with Clinical and Hospital Quality Management staff for completion and review of relevant Hospital Event Reports.
• Participates in projects as assigned.

Operational Quality Control and Quality Assurance:

• Plans and facilitates the writing and revision of SOPs, forms, and other critical documents.
  
• Responsible for the document control process of all required SOPs, forms, and other critical documents needed for accreditation requirements. 
  
• Responsible for preparation of validation protocols, documentation of results, statistical analyses, and generation of reports, and ensuring appropriate approval of validation results prior to implementation.
  
• Collaborates with other departments when revisions to their policies/procedures are required and/or needed for accreditation requirements.
  
• Coordinates reporting of all Clinical Program and Apheresis Unit deviations, evaluates corrective action taken, and communicates relevant information to appropriate stakeholders.
  
• Evaluates any preventative actions needed to help decrease recurrence of trends, ensures implementation and documentation of any preventative action taken, and evaluates effectiveness of such actions.
  
• Coordinates with the Apheresis Unit to ensure documentation, investigation, and reporting of adverse reactions to cell product collection and product deviations. 
  
• Coordinates with the Apheresis Unit to ensure proper equipment performance testing, preventative maintenance, and malfunction documentation to ensure that equipment meets performance requirements.
  
• Coordinates with the Apheresis Unit to ensure collection supplier and facility qualifications are met. 

Process Improvement Facilitation:

• Performs and provides leadership and oversight for topic-specific, continuous improvement activities, including internal and external: data collection, data review, reporting, problem identification, process improvement activities, and ongoing monitoring.

Other Duties as Assigned

• Bachelor’s degree in a healthcare related field or in a scientific field, related to oncology and/or stem cell
  transplantation.
• 5 years of experience in quality assurance/management practices, quality control, and validation protocols

Job Related Knowledge, Skills and Abilities (Competencies):

• Strong working knowledge of word processing and spreadsheet programs.
  
• Strong analytical skills.
  
• Must be able to perform the essential functions of the position with or without accommodation

• MHA, MPH, MBA
• Quality management certification
• Experience in quality management activities associated with stem cell collection and/or processing.
• FACT inspector
• Quality management certification
• Working knowledge of database applications.
• OPEx Leader Training or equivalent

This position works in a fast-paced environment with many interruptions and multiple conflicting priorities. This position works with people at all levels of the organization and interacts with numerous internal and external customers. The work environment involves everyday risks or discomforts which requires normal safety precautions typical of such places as offices and meeting rooms (i.e. use of safe work practices, avoidance of trips and falls, and observance of fire regulations and traffic signs). Work schedule anticipated to be Monday – Friday with the possibility of occasional weekend hours in order to meet deadlines

 

Benefits:

• Healthcare Options - Covered 100% for full-time employees and 88% for dependents, and $25K of term life insurance provided at no cost to the employee
  
• Two separate above market pension plans to choose from
  
• Vacation- up to 200 hours per year depending on length of service
  
• Sick Leave- up to 96 hours per year
  
• 8 paid holidays per year
  
• Substantial Tri-met and C-Tran discounts
  
• Additional Programs including: Tuition Reimbursement and Employee Assistance Program (EAP)
  

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.