Quality Assurance Manager - CLIA​/CAP Laboratory

Quality Assurance Manager - CLIA/CAP Laboratory About The Role

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 build‑out 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.

• 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.

• 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.

• A Builder mentality – motivated by creating compliant, fit‑for‑purpose systems from the ground up.
• Hands‑on and detail‑oriented,…