Quality Manager for Complexity CLIA Lab

Overview

Nanobiosym is an innovative company in Cambridge, MA that is developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. This hypergrowth company allows for unique career opportunities with strong long-term incentives. Nanobiosym is currently seeking top notch candidates to help the company scale up its operations.

Nanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. The role and requirements are below. The CLIA Quality Manager will provide quality and compliance oversight to the Nanobiosym diagnostic testing laboratory. This is a highly specialized role that requires the ability to apply CLIA requirements across the laboratory.

Job Description:

The position will lead the quality management program for the CLIA laboratory in accordance with regulatory standards and the Nanobiosym quality management system. 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, provide leadership and guidance re: CLIA and associated regulations, and support the Lab Director and leadership in maintaining audit readiness.

This position formally serves additional regulatory roles applicable to CLIA, CAP and other accredited bodies. The position 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.

• Maintain Licensure by ensuring all CLIA and state licenses are renewed in a timely manner.
• Implement CAP (College of American Pathologists) testing and any required reporting.
• Along with the CLIA Lab Director and leadership, maintain laboratory audit readiness by overseeing and managing clinical lab audits with regulators, pharmaceutical partners, and with other agencies, ensuring that internal system and process audits are scheduled and conducted.
• Lead and coordinate timely resolution of any audit findings. However, the goal is NO Findings.
• Lead the CLIA Quality Management Program to maintain and improve a QMS that is compliant with the 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, ensuring a timely resolution and thorough documentation.
• 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.
• Ensure the timely and compliant generation of clinical and validation data required to support regulatory submissions for all new products and modifications to existing products.
• Align early assay development procedures and ensure appropriate validation/verification documentation for new releases and changes to the product.
• Ensure documentation of personnel qualifications, competency, and trainings are managed and maintained.
• As part of CAP or other external proficiency testing programs ensure records are complete and accurate to include enrollment, documentation and performance monitoring.
• Review all new and revised standard operating procedures, including periodic review. Establish and maintain standard operating procedures for CLIA quality & compliance.
• Provide leadership and be a resource to staff regarding CLIA and related regulations and best practices, including maintaining knowledge of applicable regulations, providing consultation to staff regarding regulatory compliance.

• Minimum 8 years' working in an FDA regulated industry and experience interfacing with regulatory bodies. Medical device and/or in vitro diagnostics industry experience required.
• Bachelor of Science degree in medical technology, laboratory sciences or scientific disciplines.
• Medical device and/or in vitro 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.
• Demonstrated ability to work independently, exercise good judgment, to work…