Quality Manager for High Complexity CLIA Lab
1 week ago
Nanobiosym, a pioneering company in Cambridge, MA, is seeking a highly skilled Quality Manager for its High-Complexity Testing CLIA LAB. This role requires expertise in applying CLIA requirements across the laboratory.
The CLIA Quality Manager will lead the quality management program for the CLIA laboratory in accordance with regulatory standards and the quality management system at Nanobiosym. Key responsibilities include ensuring licensure, implementing CAP testing, and maintaining laboratory audit readiness.
Key Responsibilities:
- Maintain licensure by ensuring all CLIA and state licenses are renewed in a timely manner.
- Implement CAP testing and required reporting.
- Oversee and manage clinical lab audits with regulators, pharmaceutical partners, and other agencies.
- Lead and coordinate timely resolution of audit findings.
- Lead the CLIA Quality Management Program to maintain and improve a QMS that is compliant with applicable regulations and standards.
- Oversee, monitor, and/or participate in CLIA-related capital appropriation requisitions and establish quality agreements for business partnership agreements.
- Lead and monitor deviations and corrective and preventative actions.
- Develop dashboards for monthly reporting of significant issues or trends related to quality of activities for which the clinical laboratory is responsible.
- Ensure lab systems are performed in compliance with regulations.
- Identify, assess, and manage quality risks or compliance concerns proactively.
- Assure suppliers meet business and regulatory expectations.
- Ensure the timely and compliant generation of clinical and validation data required to support regulatory submissions.
- Align early assay development procedures and ensure appropriate validation/verification documentation.
- Ensure documentation of personnel qualifications, competency, and trainings.
- Review all new and revised standard operating procedures.
Qualifications:
- Minimum 8 years' working in an FDA regulated industry and experience interfacing with regulatory bodies.
- Bachelor of Science degree in medical technology, laboratory sciences, or scientific disciplines.
- Medical device and/or invitro diagnostics industry experience required.
- Minimum 8 years' experience in clinical laboratories performing high complexity testing.
- Minimum of 5 years' experience in CLIA laboratories, accreditation requirements, and applicable regulations.
- Minimum of 5 years' experience with GCP/GCLP regulations and testing in support of clinical trials.
- Effective verbal and written communication skills and attention to detail with an ability to work in a regulated environment.
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