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Quality Manager

5+ years
Not Disclosed
10 April 28, 2025
Job Description
Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Quality Manager
Job ID: 259927
Category: Regulatory/Compliance
Location: Overland Park, Kansas, United States
Job Type: Full-Time
Remote: No

About the Role
Labcorp is seeking a Quality Manager for its laboratory in Overland Park, KS. This role requires expertise in Laboratory Quality Management within a clinical and regulatory environment, particularly with CLIA, CAP, ISO 15189, and other regulatory requirements. You will manage the overall quality and regulatory compliance for satellite labs and POCT testing at client medical centers, with essential regional travel. The position is based in Overland Park, KS, and is not remote.

Key Responsibilities

  • Manage quality programs, systems, and procedures to ensure compliance with regulatory and accreditation requirements.

  • Lead the internal and external audit program, resolving audit and inspection findings.

  • Oversee proficiency testing, nonconforming event programs, and continuous improvement activities.

  • Ensure compliance with regulatory requirements such as CLIA, CAP, ISO 15189, and other standards.

  • Serve as a liaison between external regulatory agencies and laboratories.

  • Facilitate process improvement activities and interpret outcomes of root cause analysis, corrective action, and effectiveness checks.

  • Maintain knowledge of current industry trends, standards, and methodologies.

  • Formulate responses to accreditation and regulatory citations, nonconforming events, and complaints.

  • Provide guidance to laboratories on implementing policies related to regulatory and accreditation requirements.

  • Collect and present summary data for management reports, including quality indicators, audit outcomes, and complaints.

  • Travel regionally (25-30%) to support quality programs and conferences.

Requirements

  • BA/BS degree in Biology, Chemistry, Medical Technology, or related science.

  • 5+ years of experience in Quality Assurance/Quality Management.

  • 2+ years of people leadership or operations experience preferred.

  • Experience in diagnostics laboratory strongly preferred.

  • Ability to travel regionally (25-30% of the time).

Why Labcorp?
Labcorp values its people, offering a supportive environment for growth and development. As a part of Labcorp, you’ll be working with industry leaders dedicated to improving health and lives.

Salary and Benefits

  • Comprehensive benefits for employees working 20+ hours per week, including Medical, Dental, Vision, Life Insurance, 401(k), Paid Time Off (PTO), Tuition Reimbursement, and Employee Stock Purchase Plan.

Labcorp is an Equal Opportunity Employer
Labcorp is committed to diversity and inclusion in the workforce and does not tolerate harassment or discrimination. Employment decisions are based on business needs and individual qualifications.