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.

About 10x Genomics

At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.

We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.

Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference. 

Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.

10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.

Please be aware of recruitment scams impersonating 10x Genomics. All recruiting communication will come from email addresses @10xgenomics.com. We also want to encourage you to apply to 10x Genomics positions directly on our careers site, Careers.10xgenomics.com or from reputable third party sites, such as LinkedIn or Indeed.  We will never request payment or sensitive personal information during the recruiting process.