Quality Assurance Manager - CLIA/CAP Laboratory

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 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.

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

Benefits

• Comprehensive health and retirement benefit programs
• Annual bonus program or sales incentive program
• Equity grants