The Quality Manager is responsible for the
Quality programs, systems, processes and procedures and that the
performance and quality of services conform to established
regulatory and accreditation requirements within the assigned
laboratory or geographic region. Leads the internal and external
audit program and resolution of audit and inspection findings;
manages the internal and external proficiency testing program,
manages the nonconforming event program and facilities continuous
improvement. Oversees compliance with CLIA, CAP, ISO 15189 and
other regulatory and accreditation requirements.
Promotes a culture of quality.
Partners with laboratory leadership to develop quality goals and
Develops positive and supportive working relationships with
laboratory management in the assigned areas.
Ensures all laboratories within the assigned areas maintain current
federal, state and local licensure and accreditations, as
applicable. Maintaining a regulatory readiness at all
Provides guidance for laboratories in implementing policies with
respect to regulatory and accreditation requirements.
Audits laboratories to identify quality issues, nonconformities and
opportunities for improvement.
Oversight of proficient testing program.
Formulates responses to accreditation and regulatory citations,
nonconforming events and complaints.
Monitors outcomes of root cause analysis, corrective action and
10) Facilitates process improvement activities.
11) Prepares and lead monthly Quality Meetings and records
accurate minutes to communicate site progress as measured by Key
12) Collects summary data for management reports regarding
quality indicators, internal and external audit outcomes, and
13) Participates and/or leads in Quality meetings, Improvement
teams and Regulatory initiatives.
14) Provides and ensures training for LabCorp quality policies
15) Maintains and coordinates communications between
laboratories in the assigned areas, provides assistance where
indicated on quality related issues.
16) Provides excellent communication with the Divisional Quality
17) Other job duties as applicable.
License/Certification/Education: Normally a B.A./B.S. in
Biology w/4-5 years of Clinical Laboratory experience.