Sr. Manager, Quality Assurance
Core
Overseeing quality activities, audit/compliance programs, and QMS for Tempus labs to ensure adherence to global regulations and support precision medicine.
Role type
Senior Manager, Quality Assurance (Clinical Laboratory/Medical Device)
Builds
Quality Management System (QMS) activities and audit/inspection readiness for clinical labs
Domain
Healthcare / Precision Medicine / Clinical Laboratory / Medical Device
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QA audits, CAPA management, Document Control, regulatory compliance, team leadership, project management, strategic execution
Preferred skills
Class 2/3 medical device development, molecular testing laboratory (LDTs) experience
Technologies
eQMS, FDA 21 CFR 820, ISO 13485, CAP/CLIA/NYS regulations
Responsibilities
Lead internal and external regulatory inspections/audits; Manage audit findings via NC and CAPA; Oversee eQMS implementation and automation; Develop fit-for-purpose QMS policies; Direct and develop reporting staff; Provide input on quality assurance metrics
Seniority
Senior, hands-on IC with management responsibilities
