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Quality Assurance Manager - CLIA/CAP Laboratory

1 week, 5 days ago
United States
Full-time
Lead
QA Engineer
Quality Assurance and Testing
Apply Now
10x Genomics

10x Genomics

10x Genomics provides innovative genomics tools that enable researchers to explore single-cell and spatial biology, facilitating groundbreaking discoveries that enhance understanding of health and disease to improve human health outcomes.

Biotechnology
1K-5K
Founded 2012
$243M raised
View All Jobs 26

Description

  • Implement document control, deviation/CAPA, training, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations.
  • Develop and manage SOPs and work instructions in collaboration with CLIA and assay development teams.
  • Integrate the laboratory’s quality infrastructure into 10x Genomics’ enterprise-wide quality management system.
  • Establish and track quality metrics for laboratory operations, including deviations, nonconformances, complaint handling, audit findings, and proficiency testing.
  • Ensure inspection readiness and support regulatory submissions for CLIA, CAP, and state licensure.
  • Review and approve validation plans, QC data, reports, and change control documentation for laboratory methods and assay software components.
  • Support management of reagents, instruments, workflow changes, and onboarding/verification of transferred LDTs.
  • Serve as the quality liaison with external auditors and partners.
  • Recruit, train, and manage a small QA team as laboratory operations scale.
  • Partner with operations, assay development, bioinformatics, IT, and quality/regulatory leaders to support compliant workflows and data integrity.

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Medical Laboratory Science, Quality Management, or a related field.
  • 10+ years of quality assurance experience in a regulated clinical laboratory environment.
  • Experience building or expanding quality systems in a CLIA laboratory.
  • Strong working knowledge of CLIA and CAP quality and documentation requirements.
  • Experience preparing for and leading CAP inspections and CLIA audits.
  • Experience with LIMS, electronic QMS tools, and training management systems.
  • Excellent written and verbal communication skills and the ability to collaborate across scientific, operational, and regulatory functions.
  • Hands-on, proactive, and adaptable approach suited to an early-stage, fast-growing diagnostic environment.
  • Additional knowledge of FDA 21 CFR Part 820 and ISO 13485 is strongly preferred.
  • Builder mentality, with the ability to create compliant systems from the ground up and grow into people leadership.

Benefits

  • Base salary range of $132,800 to $179,600 USD.
  • Eligible for equity grants.
  • Comprehensive health benefits.
  • Retirement benefit programs.
  • Annual bonus program or sales incentive program.
  • Opportunity to work in a mission-driven, inclusive environment focused on advancing genomic technologies.
  • Potential to grow into leadership of a small QA team.

Interested in this position?

Apply directly on the company website

Apply Now

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