We are seeking a highly motivated hands-on manager to join us as a Quality Manager, Clinical Laboratory Operations. This position is responsible for the execution and effectiveness of Clinical Laboratory Quality System in accordance with the GRAIL’s Quality Management Systems and regulatory standards/requirements such as Current Good Manufacturing Practices (cGMPs), GCP, ISO 13485:2016, ISO 15189, 21 CFR Part 820, 21 CFR Part 493 (CLIA), CAP, and New York State Department of Health (NYSDOH).
- Provide oversight of all aspects of the laboratory’s quality management system to ensure conformance to requirements described in the GRAIL Quality Management System and drive/support Corporate QMS initiatives and continuous improvement activities.
- Responsible for overseeing proficiency testing program; non-conforming event program and monitoring trends for preventive action.
- Prepare and lead Quarterly Quality Monitoring and Improvement (QMI) Reviews and records accurate minutes to communicate site progress as measured by Key Performance Indicators.
- Serve as a Quality expert for Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and CAP/NYSDOH accreditation standards for the laboratory.
- Responsible for performing risk assessments and working with leadership to create action plans to mitigate risk.
- Work regularly with the Medical Laboratory Director to maintain licensure and accreditation for the site.
- Responsible for leading CAPA/root cause investigations and ensuring deliverables for corrective actions are met in a timely fashion.
- Support improvements and maintenance of the Quality Management System (QMS), including ensuring the system is fully functional in the laboratory while maintaining compliance with regulatory agencies.
- Provide oversight and ensure compliance of Quality System support elements for the Clinical Laboratory: Internal Auditing, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
- Ensures and enforces organizational policies and procedures required in maintaining regulatory compliance (i.e. HIPAA, CAP, FDA, California DOH, OSHA, etc.)
- Ensures compliance with Federal, California State (BCC) and local regulations, ensuring adherence to Laboratory standards.
- Provide training, coaching, mentoring and guidance to all Clinical Laboratory personnel as well as cross-functional teams.