The Director of Quality Systems is responsible for leading the development and implementation of the Quality Management System in alignment with ARUP’s overall business strategy. The Director ensures that the quality management system complies with appropriate CLIA, CAP, ISO and GxP regulations and requirements.
The Director provides strategic and proactive leadership of quality excellence in alignment with leaders in all areas of ARUP, with the overall objective of developing a culture of quality to meet the needs of patients, ordering physicians, clients, employees, and regulatory and accrediting agencies.
Provide leadership for the Quality function through development and implementation of the Quality Management System. Develop, implement and monitor specific strategic quality objectives in alignment with business organization objectives.
Provide leadership for the development and implementation of ARUP’s document management system including Policies, Processes, and Procedures (SOPs). Provide oversight and monitoring of the document review and approval process.
Assist various departments, including Medical Directorship, Research & Development, and Technical Operations to define and implement a structured assay/product development and validation process consistent with the strategic direction of the business and regulatory requirements.
Work in collaboration with all ARUP departments to ensure the highest possible levels of commitment to SOPs and applicable guidance and regulations through the following activities:
education of company personnel on regulations and requirements by regulatory agencies
process evaluation and continuous improvement practices
system and equipment calibration and validation
development, trending and reporting of quality metrics
internal auditing of adherence to the Quality Management System at all levels
development of a culture consistent with The Five Pillars of ARUP
Serve as a subject matter expert on matters of quality to ensure a system that promotes “inspection readiness” of the operations.
Serve as primary Quality Management System contact for regulatory inspections and client audits
Lead continuous improvement activities to implement best practices and enhance adherence to SOPs.
Assist with the supplier qualification process and with resolving quality issues related to vendors and suppliers.
Oversees CAP and ISO accreditation activities.
Supervises support staff.
Develops and manages budgets.
Educates ARUP clients and prospective clients about the strengths of the Quality Management System.
Chairs the ARUP Management Review Committee.
Participates as a member of various ARUP committees, including the Policy & Procedure Committee and the Corporate Compliance Committee.
Other duties as assigned.
Master’s degree in Quality Management, Regulatory, Public Health, Healthcare Management or other applicable field.
Strong working knowledge of CLIA, CAP, FDA, ISO, and other requirements applicable to clinical laboratories
ASQ Certification in applicable field
Strong leadership and project management skills
Five years of experience in designing and implementing quality systems in the clinical laboratory field
Understanding of regulatory requirements for validated systems for clinical trials and companion diagnostics.
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 and effectively communicates 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.
Authorized to Work: Must be a citizen of the United States or authorized to work in the United States.
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, including the human body.
Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.
English: Ability to speak, read, and comprehend the English language.
Continuing Education: Continual assessment of current literature and best practices.
ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and a worldwide leader in innovative laboratory research and development. A nonprofit enterprise of the University of Utah, ARUP offers an extensive test menu of highly complex and unique medical tests.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without re...gard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.