Quality Assurance Manager - CLIA/CAP Laboratory

10x Genomics•Pleasanton, CA

About The Position

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.

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 Haves

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.

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.