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Clinical Quality Manager

  • Location: Boulder
  • $ Salary: Negotiable per year
  • Job Type:Permanent

Posted 25 Tage her

Clinical Quality Manager


*Prefer on-site with some flex for hybrid*


The Clinical Quality Manager will be responsible for establishing and maintaining quality processes and improvement initiatives for regulated products and clinical testing, specifically supporting the GCP/CLIA laboratory. This role will operationalize quality systems, to ensure regulatory compliance. The Clinical Quality Manager will also manage internal and external communication with regulatory agencies overseeing the clinical laboratory and ensuring all applications, systems, products and procedures meet defined quality standards.


  • Provide quality management support by ensuring services, processes, facilities, reporting, investigations, audits, and systems are in compliance with FDA GLP/GCP, ISO 15189, CAP/CLIA, and NYSDOH standards and regulations
  • Ensure quality processes and systems maintain a high level of standards and patient care that meet business needs
  • Maintain and drive the creation of clinical programs to ensure compliance to FDA GLP/GCP, CAP/CLIA, NYSDOH, and applicable CFR regulations
  • Provide front-room representation for clinical regulatory inspections
  • Categorize audit/inspection findings, and drive finding responses and closure
  • Define and maintain quality metrics to measure, analyze, and implement processes to monitor and improve quality
  • Develop and support infrastructure to measure performance of quality systems against established standards and design reports and readouts for leadership
  • Manage and perform quality review of procedural documentation to ensure deliverables adhere to standards
  • Identify and evaluate issues and/or gaps in processes and documentation, and propose effective solutions to remediate
  • Track and develop effectiveness reports based on internal requirements
  • Specialize in developing, planning and executing audits to ensure compliance with regulatory standards and procedures
  • Manage clinical quality audit program, including analysis, assessment and compliance risk
  • Review pre and post remediation documentation and drive corrective actions
  • Review and answer vendor document questions, in partnership with cross-functional teams
  • Manage and maintain an internal and external vendor auditing program and proficiency testing
  • Lead risk management activities to resolve issues stemming from NCRs, CAPAs, and Audits
  • Own quality control and quality assurance activities; responsible for writing, reviewing and analyzing the clinical audit documentation
  • Maintain eQMS and provide document control support
  • Ensure accuracy and completeness for all equipment IQ/OQ/PQ, and support the creation of instrument concordance processes