Sr. Manager, Quality Assurance
Core
Operational engine driving the execution, management, and continuous improvement of Tempus' clinical Quality Management System (QMS) at the intersection of AI and clinical compliance.
Role type
Senior Manager, Clinical Quality Assurance
Builds
Compliance for pharmaceutical CRO clinical operations and proprietary medical device sponsored studies
Domain
Healthcare / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
ICH-GCP knowledge, clinical audit execution, vendor qualification, CAPA management, SOP maintenance, regulatory reporting, root cause analysis
Preferred skills
People management, project lead experience, Sponsor and CRO dual experience, early-phase clinical trial experience
Technologies
Google platform, Microsoft Word, Excel, electronic QMS/clinical trial platforms
Responsibilities
Implement and maintain clinical QMS workflows, manage clinical QA audit program, conduct internal and vendor audits, manage CAPA programs, ensure regulatory compliance for clinical trials, support regulatory inspections
Seniority
Senior, hands-on IC with management responsibilities
