The Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance will facilitate implementation of Quality Management principles and tools so that optimal quality of care and research & the highest level of patient safety and outcomes can be achieved. The Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance oversees all quality assurance, quality improvement and regulatory compliance activities of the BMT Program, including Perioperative Services bone marrow collection, BMT and Hematology inpatient and ambulatory clinic areas and Cellular therapy. In addition, the Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance may be asked to assist with quality and process improvement activities for other areas such as inpatient units. The Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance will collaborate with leadership, clinical customers, and unit staff on quality projects.

• Minimum Required: Bachelor's Degree In health care required
• Preferred: Master's Degree
• Minimum Required: 3 - 5 Years equivalent experience; 5 years clinical experience preferred with experience in cellular therapy
• Preferred: 3 - 5 Years equivalent experience; Knowledge in field of quality and clinical data analysis experience in hospital/health care setting preferred.
• Formal training or experience in patient safety.

Quality Manager - 30%

• Serves as the Bone Marrow Transplant resource to establish and maintain systems to review, modify and approve all policies and procedures intended to monitor compliance with the FACT standards and/or performance of the Clinical Program.
• Develop systems for auditing Clinical Program activities to confirm compliance with the written SOPs and policies.
• Oversees the day to day management of the Clinical Program quality management plan.
• Assess the stability, reproducibility and effectiveness of critical processes in order to continually improve the programs efficiency and patient outcomes.
• Communicates trends and opportunities for improvement to key process owners.
• Responsible for the oversight of staff training, development and execution of validation plans, auditing clinical and collection activities for compliance with all accrediting and regulatory facilities, monitoring all equipment maintenance and provide quarterly reports to Bone Marrow Transplant Clinical Program supported by Hoxworth Blood Center collection and processing facilities.
• Chairs BMT Program Quality meeting, prepares agendas and minutes of meetings in a timely manner and ensures completion of meeting action items.
• Prepares an annual quality report meeting all the FACT guidelines.
• Manages archiving and retention of outdated documents.
• Manages Operations Committee.
• Serves as a facilitator for Swarms in assigned areas where appropriate.
• Oversees the Data Management collection, entry and submission of data to CIBMTR.
• Assists with oncology service line quality outcomes.
• Assists with the completion of payer RFIs. Manages projects as assigned.

Accreditation and Regulatory Compliance - 30%

Responsible for accreditation surveys and readiness.

Serves as the organizational resource on interpretation of FACT (Foundation for the Accreditation of Cellular Therapy) standards, as well as, the Joint Commission standards, CMS Conditions of Participation and ODH by developing and maintaining expert knowledge.

Monitors and manages all FACT standards.

Manages, coordinates and directs operational and patient care services in ongoing survey readiness.

Coordinates inspections by regulatory and accrediting agencies, prepares response to inspection reports and ensures timely implementation of corrective measures.

Serves at the organization liaison to UC Health Corporate Compliance department.