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 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.

What you will be Doing:

Clinical Quality Framework Establishment and Oversight

• 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).

Operational Quality Support

• 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.

Team Leadership and Growth

• 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.

Cross-Functional Collaboration

• 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.

To be successful, you will Need:

• 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.

It would be advantageous if you Have:

• 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.

Impact:

The Quality Assurance Manager - CLIA/CAP Laboratory, will be instrumental in establishing 10x Genomics’ diagnostic quality foundation. This role ensures that every assay and clinical result produced under the CLIA/CAP framework meets the highest standards of accuracy, reliability, and compliance—paving the way for 10x to deliver transformative precision medicine insights.