Quality Assurance Manager - CLIA/CAP Laboratory
About The Position
Establish and track key quality metrics for laboratory operations (e.g., deviations, nonconformances, complaint handling, audit findings, proficiency testing). Provide day-to-day quality oversight of clinical laboratory operations, including review and approval of validation plans, QC data, and reports. 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 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. 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. Experience preparing for and leading CAP inspections and CLIA audits. Experience with LIMS, electronic QMS tools, and training management systems is required. 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.
Requirements
- Experience with LIMS, electronic QMS tools, and training management systems is required
- 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
Responsibilities
- Establish and track key quality metrics for laboratory operations (e.g., deviations, nonconformances, complaint handling, audit findings, proficiency testing)
- Provide day-to-day quality oversight of clinical laboratory operations, including review and approval of validation plans, QC data, and reports
- 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
- 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
- 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
- Experience preparing for and leading CAP inspections and CLIA audits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
1,001-5,000 employees
