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Quality Manager for High Complexity CLIA Lab

1 month ago

Cambridge, Massachusetts, United States Nanobiosym Full time

Nanobiosym is a leading company in the development of novel technologies to address a broad range of diseases.

This position will lead the quality management program for the CLIA laboratory in accordance with the 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 re: CLIA and associated regulations, and support 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.

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.

Key Responsibilities:

  • 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, 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.

Qualifications:

  • Minimum 8 years' working in an FDA regulated industry and experience interfacing with regulatory bodies. Medical device and/or invitro diagnostics industry experience required.
  • 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.
  • Demonstrated ability to work independently, exercise good judgment, to work collaboratively in an interdisciplinary team with minimal direction, and to thrive in a fast-paced environment.
  • Have excellent problem solving and delegation skills with demonstrated leadership ability.