Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: RML Administration
Work Type: Full Time (Total FTE between 0. 9 and 1. 0)
Shift: Shift 1
Work Schedule: 8 Hr (8:00:00 AM - 5:00:00 PM)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).
Pay Range: $63.10 - $106.01 per hour
Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush’s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
Job Summary:
Under the direction and guidance of the AVP Laboratory System and CLIA Lab Medical Directors, the Director of Laboratory Quality and Regulatory Compliance is responsible for overseeing and ensuring adherence to all laboratory quality, safety, and regulatory policies, procedures, and initiatives across RUSH laboratories, including RUMC, RCMC, ROPH, and off-campus laboratories. The role includes developing, implementing, monitoring, analyzing, investigating, communicating, and educating on quality management, compliance, safety, and regulatory functions to ensure high-quality laboratory testing, a safe work environment, and adherence to all regulatory requirements. This position will lead and direct the oversight for the Point of Care Testing Program for the System.
Job Responsibilities
Quality System Management:
•Develops and maintains quality management policies and procedures to comply with various regulatory and accreditation agencies.
•Establishes, monitors, and communicates laboratory performance indicators.
•Ensures continuous performance improvement is maintained.
•Oversees corrective action implementation and documentation for identified issues.
•Collaborates with laboratory managers and directors to identify and implement performance improvement initiatives.
•Conducts internal audits to ensure quality management activities are properly performed and documented.
•Serves as a member of the Quality Assurance Committee and represents the laboratory in the medical center’s Environment of Care Committee.
•Engages with the medical center’s Quality Office as necessary.
•Develops and implements the overall lab best practice teams (BPT)
•Facilitates the laboratory governance committees for test utilization, reference laboratory process, point of care testing, technology, and information system prioritization.
Safety Oversight:
•Serves as the Chairperson for the Laboratory Safety Committee.
•Participates in the medical center’s Emergency Preparedness Committee and Daily Safety Briefing.
•Develops and maintains safety policies and procedures to comply with all regulatory and accrediting agency requirements.
•Coordinates fire and emergency drills and implements new safety guidelines as needed.
•Oversees safety education and training of all laboratory personnel.
•Conducts routine internal safety audits to ensure compliance with policies and ergonomic guidelines.
•Evaluates personal protective equipment needs to ensure adequate protection.
•Monitors laboratory personnel exposures, accidents, and injuries and consults with Employee Health, Infection Control, and Occupational Safety as necessary.
Regulatory Compliance:
•Develops and maintains policies and procedures to ensure the laboratory remains in a state of readiness for accreditation and regulatory inspections (e.g., CLIA, CAP, AABB, FDA, OSHA, TJC, ASHI, FACT, IDPH).
•Oversees internal or mock inspections to maintain ongoing compliance.
•Ensures personnel records are maintained, including required education, certification, training, and competency documentation.
•Collaborates with department directors, managers, and supervisors to ensure regulatory compliance across all Rush laboratories.
Point-of-Care Testing (POCT):
•Oversees the management and quality assurance of POCT programs to ensure compliance with regulatory standards.
•Works with clinical teams to optimize POCT processes and outcomes.
•Implements standardized procedures and training for POCT across all sites.
Leadership and Staff Development:
•Supervises and mentors laboratory supervisors and quality personnel to foster professional growth and development.
•Promotes a culture of accountability, collaboration, and excellence within laboratory teams.
•Ensures all staff are adequately trained on quality and regulatory requirements.
Process Improvement:
•Uses data-driven approaches to identify areas for process improvement in laboratory operations.
•Leads initiatives to enhance efficiency, reduce errors, and improve patient outcomes.
•Implements and monitors corrective and preventive actions (CAPA) to address quality issues.
Required Job Qualifications:
• Bachelor’s degree in Medical Laboratory Science, Clinical Laboratory Science, or a related field
• Master’s degree in business administration, clinical laboratory sciences, or other healthcare related field.
• 3 years or more experience of laboratory accrediting and licensure standards and requirements.
• 3 years of experience with laboratory and hospital electronic information systems.
• Strong analytical, problem-solving, and attention-to-detail skills.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to lead and manage projects effectively in a team setting.
• Ability to prioritize, organize, and complete multiple tasks within designated deadlines.
• Proficiency in data analytics.
Preferred Job Qualifications:
• MLS (ASCP) certification highly desired, along with previous laboratory safety and quality experience.
• Training in Lean and Six Sigma preferred.
• Previous healthcare supervisory experience in an integrated healthcare system preferred.
• Certificate in quality assessment, process improvement, and project management are preferred.
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
