Senior Quality Assurance Manager for CLIA Laboratory

2 weeks ago

Cambridge, Massachusetts, United States Nanobiosym Full time
Position Overview

Nanobiosym is a pioneering organization focused on developing cutting-edge technologies to combat a wide array of diseases. Founded by an MIT/Harvard graduate, the company operates at the intersection of physics, nanotechnology, and biomedicine. This rapidly expanding firm offers unique career pathways with substantial long-term benefits.

We are currently in search of a Quality Manager for our High-Complexity Testing CLIA Laboratory. Below are the key responsibilities and qualifications for this critical role.


Role Responsibilities

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

  • Ensure all CLIA and state licenses are maintained and renewed promptly.
  • Implement CAP (College of American Pathologists) testing protocols and manage necessary reporting.
  • Collaborate with the CLIA Lab Director to uphold laboratory audit readiness, managing audits with regulatory bodies and partners.
  • Lead the resolution of audit findings, aiming for zero discrepancies.
  • Direct the CLIA Quality Management Program to enhance and maintain a compliant Quality Management System (QMS).
  • Oversee capital appropriation requests related to CLIA and establish quality agreements for partnerships.
  • Manage deviations and corrective actions, ensuring timely resolution and comprehensive documentation.
  • Develop dashboards for monthly reporting on significant quality-related issues or trends.
  • Ensure compliance with regulations regarding laboratory 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 to support regulatory submissions for new and modified products.
  • Align early assay development procedures with appropriate validation documentation for new releases.
  • Maintain records of personnel qualifications, competencies, and training.
  • Ensure completeness and accuracy of records for external proficiency testing programs.
  • Review and maintain standard operating procedures for CLIA quality and compliance.
  • Provide leadership and guidance to staff regarding CLIA regulations and best practices.
Qualifications

The ideal candidate will possess:

  • A minimum of 8 years of experience in an FDA-regulated environment, with direct interaction with regulatory agencies.
  • A Bachelor of Science degree in medical technology, laboratory sciences, or related scientific fields.
  • Experience in the medical device and/or in vitro diagnostics sectors.
  • At least 8 years of experience in clinical laboratories conducting high-complexity testing.
  • A minimum of 5 years of experience in CLIA laboratories, with a strong understanding of accreditation requirements.
  • At least 5 years of experience with GCP/GCLP regulations and testing in support of clinical trials.
  • Excellent verbal and written communication skills, with a keen attention to detail.
  • Proven ability to work independently and collaboratively in a fast-paced, interdisciplinary environment.
  • Strong problem-solving and leadership skills.

We look forward to finding a qualified candidate who is ready to contribute to our mission at Nanobiosym.

  • Quality Assurance Lead for Advanced CLIA Laboratory

    2 weeks ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym 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...

  • Quality Assurance Lead for Advanced CLIA Laboratory

    7 days ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym is a pioneering organization dedicated to developing cutting-edge technologies aimed at combating a wide array of diseases. Founded by an esteemed MIT/Harvard graduate, the company operates at the intersection of physics, nanotechnology, and biomedicine. As a rapidly expanding enterprise, Nanobiosym offers exceptional career...

  • Lead Supervisor for Advanced CLIA Laboratory

    2 weeks ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym is a pioneering organization located in Cambridge, MA, dedicated to creating innovative solutions for a wide array of health challenges. Founded by an alumnus of MIT and Harvard, the company operates at the cutting edge of physics, nanotechnology, and biomedicine. As a rapidly expanding enterprise, we offer exceptional career...

  • Lead Supervisor for Advanced CLIA Laboratory

    7 days ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym is a pioneering organization focused on developing cutting-edge technologies to combat a wide array of health challenges. With roots in prestigious institutions, we are at the forefront of innovation, merging physics, nanotechnology, and biomedicine. Our rapid growth offers exceptional career paths with significant long-term...

  • Lead Supervisor for Advanced CLIA Laboratory

    2 weeks ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym is a pioneering organization focused on creating cutting-edge technologies aimed at tackling a wide array of health challenges. Founded by an esteemed MIT/Harvard graduate, our company operates at the convergence of physics, nanotechnology, and biomedicine. We are in a phase of rapid growth, presenting exceptional career prospects...

  • Lead Technical Supervisor for Advanced CLIA Laboratory

    7 days ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Company Overview:Nanobiosym is a pioneering organization located in Cambridge, MA, focused on the creation of innovative technologies aimed at addressing a variety of health challenges. Established by an alumnus of MIT and Harvard, the company operates at the intersection of physics, nanotechnology, and biomedicine, providing exceptional career advancement...

  • Lead Technical Supervisor for Advanced CLIA Laboratory

    7 days ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym, a pioneering organization in the field of innovative healthcare solutions, is seeking a highly skilled Technical Supervisor for its High-Complexity Testing CLIA Laboratory. This role is critical in advancing our mission to develop cutting-edge technologies that address various health challenges.Key Responsibilities:Determine...

  • Lead Technical Supervisor for Advanced CLIA Laboratory

    2 weeks ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym is a pioneering organization focused on developing cutting-edge technologies aimed at tackling a wide array of health challenges. Founded by a distinguished MIT/Harvard graduate, the company operates at the intersection of physics, nanotechnology, and biomedicine. As a rapidly growing enterprise, we offer exceptional career...

  • Lead Technical Supervisor for Advanced CLIA Laboratory

    2 weeks ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym is a pioneering organization located in Cambridge, MA, focused on developing cutting-edge technologies aimed at tackling a wide array of health challenges. Founded by an alumnus of MIT and Harvard, our company operates at the intersection of physics, nanotechnology, and biomedicine. As a rapidly growing entity, we offer...

  • Senior Laboratory Manager for High-Complexity Molecular Diagnostics

    4 days ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Nanobiosym, a pioneering biotechnology company in Cambridge, MA, is seeking a highly skilled Technical Supervisor to lead its High-Complexity Testing CLIA LAB for molecular diagnostics. As a key member of our team, you will play a critical role in ensuring the highest standards of quality and accuracy in our testing processes.Key Responsibilities:Methodology...

  • High Complexity CLIA Lab Technical Supervisor

    2 days ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Job SummaryNanobiosym, a pioneering biotechnology company in Cambridge, MA, is seeking a highly skilled Technical Supervisor to lead its High-Complexity Testing CLIA Lab for molecular diagnostics.Key ResponsibilitiesTest Methodology Selection: Select and implement appropriate test methodologies for the clinical use of the test menu, ensuring accuracy and...

  • Technical Supervisor for High Complexity CLIA Lab Operations

    4 days ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Nanobiosym is a pioneering biotechnology company in the field of molecular diagnostics, seeking a highly skilled Technical Supervisor to lead its High-Complexity Testing CLIA Lab.About the Role:The Technical Supervisor will be responsible for overseeing the daily operations of the CLIA Lab, ensuring the highest standards of quality and accuracy in molecular...

  • Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States SPECTRAFORCE Full time

    Job Title: Quality Assurance Specialist - Quality SystemsLocation: RemoteDuration: Contract PositionThis position is a hybrid role with scheduled work hours Monday to Friday, 8:30 AM to 5:00 PM, requiring onsite presence based on project needs.Key Responsibilities:The Quality Assurance Specialist operates within the Quality Systems division and collaborates...

  • Clinical Quality Assurance Senior Manager

    2 weeks ago

    Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    Senior Manager of Clinical Quality AssuranceChampion adherence to Good Clinical Practice (GCP) standardsOffer expert guidance on global GCP regulationsUtilize GCP knowledge to enhance the auditing frameworkCollaborate with study teams to foster a culture of quality within the organizationCore Responsibilities:Engage in the formulation of clinical quality...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Aequor Full time

    Senior Quality Assurance SpecialistLocation: RemoteTerms: Contract W2Duration: 12 Months Contract (Potential for Extension)Overview:This role offers a flexible schedule with a requirement for onsite presence at least two days per week.Working Hours: Monday to Friday, 8:00 AM - 5:00 PM (flexible)Ideal Candidate Profile:The ideal candidate will possess over 4...

  • Senior Quality Assurance Manager

    2 weeks ago

    Cambridge, Massachusetts, United States Relay Therapeutics Full time

    Position Overview:We are in search of a Quality Assurance leader to play a pivotal role in the development of our Quality function at Relay Therapeutics. This position involves collaboration with Clinical Development teams to manage various external contract partners while actively shaping the Quality Management System as our operations expand. This...

  • Quality Assurance Engineer

    2 weeks ago

    Cambridge, Massachusetts, United States Roche and Genentech Full time

    Job OverviewThe Quality Assurance Engineer plays a crucial role within the Quality Systems division at Roche and Genentech, collaborating with diverse teams throughout the organization. This position is essential in ensuring that the Quality Management System, Corrective and Preventive Actions (CAPA), and Non-conformance processes are not only effective but...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Cambridge, Massachusetts, United States Draper Full time

    Position Overview:Draper is a distinguished, nonprofit research and development organization based in Cambridge, MA. With a workforce exceeding 2,000, Draper addresses significant national challenges, committed to delivering effective and practical solutions. Our contributions span military defense, space exploration, and biomedical engineering, where the...

  • Quality Assurance Manager

    5 days ago

    Cambridge, Massachusetts, United States Innova Solutions Full time

    Job DescriptionJob Summary:Innova Solutions is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our products and services, and for leading cross-functional teams to develop and implement quality processes and procedures.Key Responsibilities:Develop and...

  • Senior Quality Assurance Leader

    2 weeks ago

    Cambridge, Massachusetts, United States SSi People Full time

    Note: Open to candidates who are either USC / GC / EAD; C2C applications will not be considered. Position: Quality Assurance Manager - Hybrid Role Compensation: $57/hr to $59/hr Key Responsibilities: The Quality Assurance Manager will oversee quality documentation including Deviations, CAPAs, and Change Controls, along with the review and approval of testing...