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Quality Manager, Clinical Laboratory Operations

Organization
GRAIL
Job Location
1525 O'BRIEN DRIVE
Menlo Park, CA 94025
United States
Job Description

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). 

 

You Will:

  • 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.


Requirements
  • Bachelor’s degree in a physical, chemical, biological, or clinical laboratory science and 10+ years in high complexity testing in CLIA/CAP environment; OR Master’s degree with 5+ years in high complexity testing in CLIA environment.
  • Solid knowledge of CAP, CLIA, New York State's regulations, ISO 15189, including successfully having completed multiple CAP inspections.
  • A minimum of 5 yrs experience as a Laboratory Senior Leader in managing and developing staff in a high complexity CLIA environment is required.
  • A minimum of 5 yrs experience of hosting audits and direct interaction with FDA/CAP/NYSDOH and/or other regulatory agencies.
  • Experience writing, evaluating and closing investigations, CAPAs and change control records.
  • Willingness to think outside of the box and adapt best practices to this small, but growing environment.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
  • Knowledge of testing equipment, statistical methods, validation methods, problem-solving, and control plans.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description.
  • Has a proven track record of delivering results and is action-oriented.
  • Travel will be required between 5-10% of the time domestically. 
  • Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.
About Our Organization

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com

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