Tech Stack

Description

You will establish and oversee the quality infrastructure for 10x Genomics' first CLIA/CAP-certified laboratory, ensuring compliance with CLIA, CAP, and state regulations. This hands-on leadership role involves implementing document control, deviation/CAPA systems, and audits, while supporting clinical operations and building a quality team as the lab scales.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Medical Laboratory Science, Quality Management, or related field
• 10+ years of QA experience in a regulated clinical lab (CLIA/CAP)
• Experience building or expanding quality systems in a CLIA lab
• Strong 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
• Hands-on, proactive, and adaptable
• Experience with LIMS, electronic QMS tools, and training management systems

Responsibilities

• Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and state regulations
• Collaborate with CLIA and assay development teams to develop and manage SOPs
• Integrate the CLIA lab’s quality infrastructure into the enterprise-wide QMS
• Establish and track quality metrics (deviations, nonconformances, audit findings, proficiency testing)
• Ensure inspection readiness and execute regulatory submissions (CLIA, CAP, state licensure)
• Provide quality oversight of lab operations, including review of validation plans and QC data
• Serve as QA reviewer for method validation, verification, and change control
• Manage reagents, instruments, and workflow changes per CLIA/CAP
• Support onboarding of LDTs from Diagnostic Assay Development teams
• Act as quality liaison with external auditors and partners
• Initially work as individual contributor, then recruit, train, and manage a small QA team
• Foster a culture of compliance and continuous improvement
• Collaborate with Laboratory Operations, Diagnostic Assay Development, Clinical Bioinformatics, and IT