Quality Manager for High Complexity CLIA Lab

6 days ago

Cambridge, Massachusetts, United States Nanobiosym Full time
Job Title: Quality Manager for High Complexity CLIA Lab

Nanobiosym, a pioneering company in Cambridge, MA, is seeking a highly skilled Quality Manager to oversee the quality and compliance of its High-Complexity Testing CLIA LAB.

Job Summary:

The successful candidate will lead the quality management program for the CLIA laboratory, ensuring compliance with regulatory standards and the quality management system at Nanobiosym. This role requires strong leadership and communication skills, as well as the ability to work collaboratively with cross-functional teams.

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 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 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.
Requirements:
  • 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.
  • 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.

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