Quality Assurance Lead for Advanced CLIA Laboratory

2 months ago

Cambridge, Massachusetts, United States Nanobiosym Full time
Position Overview

Nanobiosym is a pioneering organization based in Cambridge, MA, dedicated to developing cutting-edge technologies aimed at combating a wide array of diseases. Founded by an alumnus of MIT and Harvard, Nanobiosym operates at the intersection of physics, nanotechnology, and biomedicine. This rapidly expanding company offers unique career paths with substantial long-term benefits.

We are currently in search of a Quality Assurance Lead for our High-Complexity Testing CLIA Laboratory. Below are the details regarding the role and its requirements.


Role Summary

The Quality Assurance Lead will oversee quality and compliance within the Nanobiosym diagnostic testing laboratory. This specialized position necessitates a thorough understanding of CLIA regulations and their application across laboratory operations.

Key Responsibilities

Quality Management Leadership

  • Ensure all CLIA and state licenses are maintained and renewed promptly.
  • Implement CAP (College of American Pathologists) testing protocols and necessary reporting.
  • In collaboration with the CLIA Lab Director, uphold laboratory audit readiness by managing clinical lab audits with regulatory bodies and partners.
  • Facilitate the resolution of any audit findings, aiming for zero discrepancies.
  • Direct the CLIA Quality Management Program to enhance and maintain a compliant Quality Management System (QMS).
  • Oversee CLIA-related capital requisitions and establish quality agreements for partnerships.
  • Lead the management of deviations and corrective actions, ensuring timely resolutions and comprehensive documentation.
  • Develop monthly dashboards to report significant quality-related issues or trends.
  • Ensure compliance with regulations concerning lab systems, including IQ/OQ/PQs, calibrations, and maintenance.
  • Proactively identify and manage quality risks or compliance issues, taking immediate corrective actions as necessary.
  • Verify that suppliers meet both business and regulatory standards.
  • Ensure timely generation of clinical and validation data for regulatory submissions for new and modified products.
  • Align early assay development processes with appropriate validation documentation for new releases.
  • Maintain documentation of personnel qualifications, competencies, and training records.
  • Ensure complete and accurate records for proficiency testing programs.
  • Review and establish standard operating procedures for CLIA quality and compliance.
  • Provide guidance and resources to staff regarding CLIA regulations and best practices.
Qualifications

Essential Experience

  • At least 8 years of experience in an FDA-regulated environment, with direct interaction with regulatory bodies.
  • Experience in the medical device and/or in vitro diagnostics sector is required.
  • A Bachelor of Science degree in medical technology, laboratory sciences, or a related scientific field.
  • A minimum of 8 years in clinical laboratories performing high-complexity testing.
  • At least 5 years of experience in CLIA laboratories, with a solid understanding of accreditation requirements and applicable regulations.
  • Minimum of 5 years of experience with GCP/GCLP regulations and testing in support of clinical trials.
  • Strong verbal and written communication skills, with a keen attention to detail in a regulated environment.
  • Proven ability to work independently, exercise sound judgment, and collaborate effectively within interdisciplinary teams.
  • Demonstrated leadership skills with excellent problem-solving and delegation capabilities.

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