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Quality Assurance Manager - CLIA/CAP Laboratory

United States, Pleasanton 132800.00 - 179600.00 USD / Year · Job Posted January 10, 2026
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Job Description

10x Genomics is establishing its first CLIA/CAP-certified laboratory to bring cutting-edge single-cell and spatial genomic technologies into clinical practice. Reporting to the Head of Quality and Regulatory, the Quality Assurance Manager will play a pivotal role in defining, developing and implementing the lab’s quality infrastructure, ensuring compliance with CLIA, CAP, and state (including California and New York) requirements. This is a hands-on leadership role suited for a quality professional who can independently execute quality assurance (QA) responsibilities during the lab’s early buildout phase and later lead a small QA team as clinical operations scale. The ideal candidate combines deep knowledge of clinical laboratory quality systems with practical, solution-oriented execution in a fast-paced and collaborative environment.

Job Responsibility

  • Clinical Quality Framework Establishment and Oversight: Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations
  • Collaborate closely with CLIA and assay development teams to develop and manage SOPs and work instructions
  • Partner with the broader Quality/Regulatory team to integrate the CLIA lab’s quality infrastructure into 10x’s enterprise-wide quality management system (QMS)
  • Establish and track key quality metrics for laboratory operations (e.g., deviations, nonconformances, complaint handling, audit findings, proficiency testing)
  • In partnership with CLIA Lab Director, ensure inspection readiness and execute regulatory submissions (CLIA, CAP, and state licensure)
  • Operational Quality Support: Provide day-to-day quality oversight of clinical laboratory operations, including review and approval of validation plans, QC data, and reports
  • Serve as QA reviewer/approver for method validation, verification, and change control documentation for both laboratory methods and assay software components
  • Ensure effective management of reagents, instruments, and workflow changes per CLIA/CAP requirements
  • Support onboarding and verification of LDTs transferred from Diagnostic Assay Development teams
  • Act as quality liaison with external auditors and partners
  • Team Leadership and Growth: Initially serve as an individual contributor responsible for implementing and maintaining quality processes
  • As sample volume and operations expand, recruit, train, and manage a small team of QA specialists or analysts supporting lab quality activities
  • Foster a culture of compliance, continuous improvement, and scientific rigor
  • Cross-Functional Collaboration: Partner closely with Laboratory Operations, Diagnostic Assay Development, Clinical Bioinformatics, and IT teams to ensure compliant workflows and data integrity
  • Work with Quality and Regulatory leadership to align CLIA/CAP quality practices with 10x’s broader corporate systems and standards
  • Contribute to strategic planning for quality-related resources, tools, and training across diagnostic programs

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Medical Laboratory Science, Quality Management, or related field
  • 10+ years of experience in quality assurance within a regulated clinical laboratory (CLIA/CAP environment)
  • Demonstrated experience building or expanding quality systems in a CLIA lab setting
  • Strong working knowledge of CLIA / CAP quality and documentation requirements
  • Additional knowledge of FDA 21 CFR Part 820 and ISO 13485 strongly preferred
  • Experience preparing for and leading CAP inspections and CLIA audits
  • Excellent written and verbal communication skills, with an ability to collaborate across scientific, operational, and regulatory functions
  • Hands-on, proactive, and adaptable, capable of working effectively in an early-stage, fast-growing diagnostic environment
  • Experience with LIMS, electronic QMS tools, and training management systems is required

Nice to have

  • A Builder mentality – motivated by creating compliant, fit-for-purpose systems from the ground up
  • Hands-on and detail-oriented, with strong follow-through and accountability
  • Collaborative and pragmatic, balancing regulatory rigor with operational needs
  • Leadership-ready, with the ability to grow into managing a small, high-performing team
  • Mission-driven, passionate about enabling genomic technologies to transform patient care

What we offer

  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Generous time off
  • Competitive and comprehensive health benefits package
  • Easy-to-use benefits that promote wellbeing
  • Family friendly policies like parental leave
  • Award-Winning Workplace

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