Sr. Manager, Quality Assurance
Core
Overseeing quality activities across all Tempus labs, managing audit/compliance programs, and supporting the Quality Management System (QMS) for clinical laboratories.
Role type
Senior Manager, Quality Assurance
Builds
Quality Management System (QMS) activities and audit/inspection processes
Domain
Healthcare / Clinical Laboratory / Medical Device
Required skills
QA audits, CAPA management, Document Control, FDA QSR, ISO 13485, CAP/CLIA/NYS regulations, eQMS implementation, team leadership, strategic execution
Preferred skills
Class 2 or 3 medical device development, molecular testing laboratory (LDTs) experience
Technologies
eQMS
Responsibilities
Lead internal, second-party, and third-party 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 duties