Nanobiosym
Quality Manager for High Complexity CLIA Lab
Nanobiosym, Cambridge, Massachusetts, us, 02140
Company OverviewNanobiosym is an innovative company in Cambridge, MA that is developing novel technologies to address a broad range of diseases. Founded by an MIT/Harvard alum, Nanobiosym operates at the interface of physics, nanotechnology, and biomedicine. This hypergrowth company offers unique career opportunities with strong long-term incentives. We are currently seeking top-notch candidates to help scale our operations.
Position OverviewNanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. This highly specialized role requires the ability to apply CLIA requirements across the laboratory.
Job DescriptionThe CLIA Quality Manager will provide quality and compliance oversight to the Nanobiosym diagnostic testing 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, provide leadership and guidance regarding CLIA and associated regulations, and support the Lab Director and leadership in maintaining audit readiness. This position formally serves additional regulatory roles applicable to multiple CLIA, CAP, and other accredited bodies. The 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.
Position ResponsibilitiesMaintain 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 other agencies, ensuring that internal system and process audits are scheduled and conducted. Lead and coordinate timely resolution of any audit findings; goal is NO 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, ensuring 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.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 training are managed and maintained.As part of CAP or other external proficiency testing programs, ensure records are complete and accurate, including 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, maintaining knowledge of applicable regulations, and providing consultation to staff regarding regulatory compliance.
QualificationsMinimum 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.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, collaborate in an interdisciplinary team with minimal direction, and thrive in a fast-paced environment.Excellent problem-solving and delegation skills with demonstrated leadership ability.
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Position OverviewNanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. This highly specialized role requires the ability to apply CLIA requirements across the laboratory.
Job DescriptionThe CLIA Quality Manager will provide quality and compliance oversight to the Nanobiosym diagnostic testing 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, provide leadership and guidance regarding CLIA and associated regulations, and support the Lab Director and leadership in maintaining audit readiness. This position formally serves additional regulatory roles applicable to multiple CLIA, CAP, and other accredited bodies. The 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.
Position ResponsibilitiesMaintain 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 other agencies, ensuring that internal system and process audits are scheduled and conducted. Lead and coordinate timely resolution of any audit findings; goal is NO 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, ensuring 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.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 training are managed and maintained.As part of CAP or other external proficiency testing programs, ensure records are complete and accurate, including 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, maintaining knowledge of applicable regulations, and providing consultation to staff regarding regulatory compliance.
QualificationsMinimum 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.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, collaborate in an interdisciplinary team with minimal direction, and thrive in a fast-paced environment.Excellent problem-solving and delegation skills with demonstrated leadership ability.
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