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10x Genomics · 1 day ago

Quality Assurance Manager - CLIA/CAP Laboratory

Pleasanton, California, USA HQ

Full-time

Onsite

Senior Level, Lead/Staff

$133K/yr - $180K/yr

10+ years exp

10x Genomics is establishing its first CLIA/CAP-certified laboratory to bring cutting-edge single-cell and spatial genomic technologies into clinical practice. The Quality Assurance Manager will be responsible for defining, developing, and implementing the lab’s quality infrastructure, ensuring compliance with CLIA, CAP, and state requirements while leading a small QA team as clinical operations scale.

Biotechnology

H1B Sponsor Likely

Responsibilities

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)

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

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

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

Qualification

CLIA/CAP complianceQuality management systemsQuality assurance experienceFDA 21 CFR Part 820ISO 13485 knowledgeLIMS experienceCommunicationTeam leadershipCollaborative mindsetDetail-oriented

Required

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

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

Preferred

Additional knowledge of FDA 21 CFR Part 820 and ISO 13485 strongly preferred

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

Benefits

10x’s equity grants

Comprehensive health and retirement benefit programs

Annual bonus program or sales incentive program

Company

10x Genomics

Glassdoor3.5

Cells are the basic unit of life.

Founded in 2012

Pleasanton, California, US

1001-5000 employees

http://10xgenomics.com

H1B Sponsorship

10x Genomics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (41)

2024 (40)

2023 (35)

2022 (52)

2021 (34)

2020 (16)