Bone Marrow Transplant Quality/Compliance Manager

UCHealth - Cincinnati, OH

Full-time - Senior

Cincinnati, OH

Hospitals

About the position

The Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance is responsible for implementing Quality Management principles to ensure optimal quality of care and patient safety within the Bone Marrow Transplant (BMT) Program. This role oversees quality assurance, improvement, and regulatory compliance activities across various clinical areas, collaborating with leadership and staff on quality projects to enhance patient outcomes.

Responsibilities

• Establish and maintain systems to review, modify, and approve policies and procedures for compliance with FACT standards.
• Develop systems for auditing Clinical Program activities to confirm compliance with SOPs and policies.
• Oversee the day-to-day management of the Clinical Program quality management plan.
• Assess the stability, reproducibility, and effectiveness of critical processes to improve efficiency and patient outcomes.
• Communicate trends and opportunities for improvement to key process owners.
• Oversee staff training, development, and execution of validation plans, auditing clinical and collection activities for compliance.
• Chair BMT Program Quality meetings, prepare agendas and minutes, and ensure completion of action items.
• Prepare an annual quality report meeting FACT guidelines.
• Manage archiving and retention of outdated documents.
• Manage Operations Committee and facilitate Swarms in assigned areas.
• Oversee data management collection, entry, and submission to CIBMTR.
• Assist with oncology service line quality outcomes and completion of payer RFIs.
• Manage assigned projects.
• Responsible for accreditation surveys and readiness, serving as a resource on FACT and Joint Commission standards.
• Monitor and manage all FACT standards and coordinate inspections by regulatory agencies.
• Assist Corporate Compliance with auditing priorities and action plans.
• Develop regulatory reports for UC Health Governing Body and provide education on standards.
• Design and implement systems for tracking and reporting compliance efforts and outcomes.
• Ensure continuous readiness through ongoing evaluation of compliance and provide feedback to Senior Leadership.
• Collaborate with bone marrow collection facility staff to ensure equipment performance and maintenance.
• Manage supplier qualification and monitoring processes for the bone marrow collection facility.
• Plan, prioritize, and manage the writing and revisions of SOPs and other documents.
• Coordinate management of the change control process and prepare validation protocols and reports.
• Manage deviations and evaluate corrective actions taken, communicating with stakeholders.
• Document and evaluate complaints related to cell products and collaborate with Hospital Legal Services.

Requirements

• Bachelor's Degree in health care required.
• 3 - 5 years equivalent experience in a clinical setting; 5 years clinical experience preferred with experience in cellular therapy.
• Knowledge in quality and clinical data analysis in a hospital/health care setting preferred.
• Formal training or experience in patient safety.

Nice-to-haves

• Master's Degree preferred.
• Experience in cellular therapy preferred.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401k
• Paid holidays
• Flexible scheduling
• Professional development opportunities