Transfusion Medicine Quality Program Manager

About the role

The Transfusion Medicine Quality Program Manager oversees the design, governance, and performance of the Transfusion Medicine Quality and Regulatory Program. This role supports department and corporate Quality Management System (QMS) activities, including regulatory compliance and risk management, for FDA-registered ARUP Blood Donor Services, FDA-registered hospital-based blood banks, and the Immunohematology Reference Laboratory (IRL).

Responsibilities

• Establishes, implements, and maintains a comprehensive quality management framework for transfusion medicine that aligns with ARUP’s quality management system (QMS)
• Defines quality program objectives, indicators of performance using data, and metrics for success (effectiveness) aligned with regulatory and organizational expectations
• Led strategic quality initiatives and enterprise projects impacting the Transfusion Medicine program
• Serves as the primary point of contact for FDA, AABB, DNV, and other regulatory or accrediting bodies related to transfusion medicine
• Works closely with corporate Quality Systems and Support staff to align CAP, CLIA and ISO requirements to Transfusion Medicine division practices
• Leads preparation, execution, and response for internal, external, and regulatory audits and inspections
• Interprets regulatory requirements with clarity and translates them into actionable policies, procedures, and controls
• Identifies, assesses, and where applicable, assists in the mitigation of quality and regulatory risks within transfusion medicine
• Leads root cause analysis, corrective and preventive action (CAPA) development, implementation, and data-driven effectiveness monitoring
• Ensures timely escalation and resolution of quality events, deviations, and nonconformances
• Acts as a liaison between ARUP Laboratories and University Health staff to address transfusion medicine quality and regulatory opportunities
• Collaborates with Medical Directors, Patient Blood Management professionals, laboratory leadership, and operational teams to support and ensure safe and compliant transfusion practices and blood administration
• Provides expert consultation on transfusion medicine quality, regulatory interpretation, and best practices
• May present quality-related data, findings, and opportunities to hospital and/or ARUP leadership
• Drives process improvement initiatives using quality methodologies to enhance safety, efficiency, and compliance
• Promotes standardization of transfusion medicine processes and documentation across the organization
• Monitors quality trends and performance data to identify and prioritize improvement opportunities
• Establishes and supports change management, to include risk analysis and prevention for laboratory initiatives
• Provides mentorship and technical guidance to quality staff supporting transfusion medicine
• Contributes to workforce development through training, education, and competency support related to transfusion medicine quality

Requirements

This position may have direct reports in the future.

Qualifications

• Master’s degree in a relevant field (e.g., healthcare management, quality assurance, biochemistry, or a related field)
• At least 5 years of experience in transfusion medicine, quality management, or a related field
• Experience with regulatory compliance and risk management in a healthcare setting
• Strong understanding of FDA, AABB, CAP, CLIA, ISO, and DNV regulations
• Excellent communication and collaboration skills
• Ability to lead cross-functional teams and drive process improvements
• Proficiency in Microsoft Office Suite

Skills

• Quality management and regulatory compliance
• Leadership and project management
• Collaboration and communication
• Process improvement and standardization
• Regulatory interpretation and best practices

Benefits

ARUP offers a competitive benefits package including health insurance, retirement plans, and paid time off.

Pay

$XX.XX - $XXX.XX per hour based on experience and qualifications.

Schedule

Monday - Friday (40 hrs/wk) 8:00 AM - 5:00 PM