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Quality Assurance Manager - CLIA/CAP Laboratory at 10x Genomics

Pleasanton, California, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Apr, 26

Salary

0.0

Posted On

08 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, CLIA, CAP, Laboratory Operations, Validation Plans, QC Data, Audit Findings, Complaint Handling, Proficiency Testing, LDTs, Collaboration, Regulatory Compliance, Continuous Improvement, Leadership, Detail-Oriented, Data Integrity

Industry

Biotechnology Research

Description

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.

Responsibilities

Establish and track key quality metrics for laboratory operations while providing day-to-day quality oversight. Collaborate with various teams to ensure compliant workflows and contribute to strategic planning for quality-related resources.