Quality Assurance Manager - CLIA/CAP Laboratory

Quality Assurance Manager - CLIA/CAP Laboratory at 10x Genomics. Establishing quality infrastructure, ensuring compliance with CLIA, CAP, and state requirements. Hands-on leadership role in a fast-paced environment. Opportunity to grow into managing a small QA team.

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