Regulatory Program Manager Jobs in Ogden, UT (NOW HIRING)

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

Primary Purpose: The Transfusion Medicine Quality Program Manager, in partnership with medical directors and corporate quality leadership is responsible for the design, governance, and performance of the Transfusion Medicine Quality and Regulatory Program. This role provides support for department and corporate Quality Management System (QMS) activities to include regulatory compliance, and risk management activities across FDA-registered ARUP Blood Donor Services, FDA-registered hospital-based blood bank, and the Immunohematology Reference Laboratory (IRL). Coordinates and leads transfusion medicine quality initiatives and acts as a key liaison between ARUP Laboratories and University of Utah Health clinical partners.

This position operates with a high degree of autonomy and professional judgment in a highly regulated environment, ensuring compliance with applicable federal, state, and accrediting body requirements, including FDA, AABB, CAP, CLIA, ISO, and DNV as well as alignment with applicable corporate QMS activities. The Manager drives quality management, data-driven continuous improvement, audit readiness, and corrective and preventive action (CAPA) programs to ensure safe and effective manufacturing and clinical use of blood products, as well as organizational integrity.

About ARUP: ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient's life. We never forget that there is a patient behind every specimen we receive.

We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

Essential Functions:

Program Leadership & Governance

Together with medical directors and laboratory operational management, 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

Leads strategic quality initiatives and enterprise projects impacting the Transfusion Medicine program

Regulatory Compliance & Audit Management

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

Risk Management & CAPA Ownership

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

Cross-Functional & Clinical Partnership

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

Continuous Improvement & Standardization

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.

Leadership & Professional Oversight

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

Other duties as assigned.

Note: This position may have direct reports in the future.

Physical and Other Requirements:

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Frequently communicate with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Education:

Bachelor's Degree or better in Medical Laboratory Sciences or related field.

Master's Degree or better in Medical Laboratory Sciences or related field.

Experience:

Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, or related scientific field Seven years of experience in transfusion medicine, blood banking, and/or donor services with increasingly responsible positions Five years of experience in quality systems, regulatory compliance, and audit management within a clinical laboratory environment In-depth knowledge of applicable regulations and standards (FDA, AABB, CAP, CLIA, ISO) Demonstrated experience leading complex and/or cross-functional quality improvement initiatives

ASCP/AMT certification (MLS, SBB), ASQ, or equivalent Advanced training or certification in quality, regulatory affairs, or process improvement Experience working in an academic medical center or multi-institutional healthcare environment Master's degree

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.