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 requirements
Job Summary
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 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 Quality Assurance Manager - CLIA/CAP Laboratory, will be instrumental in establishing 10x Genomics’ diagnostic quality foundation.
Matching Summary
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 requirements.
Salary
Base: $132,800—$179,600 USD; Bonus/Equity: Eligible for equity grants and annual bonus program; Benefits: Comprehensive health and retirement benefit programs
Skills & Requirements
Must-have
CLIA/CAP laboratory quality infrastructure
document control
deviation/CAPA systems
training programs
internal audit processes
SOP development and management
quality metrics tracking
inspection readiness
regulatory submissions
validation plan review
QC data review
method validation review
change control documentation
reagent and instrument management
LDT onboarding support
external auditor liaison
Nice-to-have
builder mentality
detail-oriented
follow-through and accountability
collaborative and pragmatic
leadership-ready
mission-driven
Key Requirements
10+ years of experience in regulated clinical laboratory
CLIA/CAP environment experience
CLIA lab quality system building experience
Strong CLIA/CAP quality requirements knowledge
Experience with CAP inspections and CLIA audits
Experience with LIMS, electronic QMS, training management systems