Senior CLIA Compliance Manager for High-Complexity Diagnostic Testing
7 days ago
Nanobiosym is a pioneering company in Cambridge, MA that specializes in developing innovative technologies to tackle various diseases. Founded by an MIT/Harvard alum, this hypergrowth company offers unique career opportunities with strong long-term incentives.
We are seeking top-notch candidates to help the company scale up its operations.
Job DescriptionThe CLIA Quality Manager will provide quality and compliance oversight to the Nanobiosym diagnostic testing laboratory. This highly specialized role requires the ability to apply CLIA requirements across the laboratory.
This position will lead the quality management program for the CLIA laboratory in accordance with regulatory standards and the quality management system at Nanobiosym. The CLIA Quality Manager will collaborate with direct and/or delegated authority to ensure the CLIA Quality Management Systems (QMS) are effective and compliant with applicable requirements.
The position provides leadership and guidance regarding CLIA and associated regulations. It also supports the Lab Director and leadership in maintaining audit readiness. This position formally serves additional regulatory roles that are applicable to the multiple CLIA, CAP, and other accredited bodies.
This role requires extensive cross-functional interaction throughout the organization, strong liaison activities with senior management, as well as with external notified bodies and third parties including CLIA, FDA, and other global regulatory authorities.
Key Responsibilities:- Maintain licensure by ensuring all CLIA and state licenses are renewed in a timely manner.
- Implement CAP testing and any required reporting.
- Oversee and manage clinical lab audits with regulators, pharmaceutical partners, and other agencies, ensuring internal system and process audits are scheduled and conducted.
- Lead and coordinate timely resolution of any audit findings.
- 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, including IQ/OQ/PQs, calibrations, maintenance, and concordance, etc.
- Identify, assess, and manage quality risks or compliance concerns proactively and take immediate corrective action as required.
- Assure suppliers meet business and regulatory expectations.
- Generate clinical and validation data required to support regulatory submissions for all new products and modifications to existing products.
This position requires medical device and/or invitro diagnostics industry experience, with a minimum of 8 years' experience in FDA-regulated industries and interfacing with regulatory bodies. A Bachelor of Science degree in medical technology, laboratory sciences, or scientific disciplines is also required.
The estimated salary for this role is $120,000 - $180,000 per year, depending on qualifications and experience.
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