Tempus AI

Sr. Manager, Quality Assurance

Chicago · Senior

Sponsorship not specified$120k-$170kDetected 26 days ago

GCPExcelClinical TrialsClinical ResearchPatient CareFDA RegulatoryMedical DevicesResearchLeadershipCommunicationMicrosoft Office

About the role

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way.
As the Director of Quality Assurance (QA), you will hold ultimate accountability for the management, strategic oversight, and scaling of Tempus' clinical Quality Management System (QMS) and team.
Operating at the intersection of cutting-edge AI and clinical compliance, you will ensure our global systems operate in accordance with ICH-GCP and applicable international regulations.

Collaborate with Executive Management to lead, implement, and continuously improve the clinical QMS, establishing quality goals and initiatives, and ensuring compliance to applicable global regulations and standards, such as FDA and ICH.
Manage and conduct qualification and ongoing audits of vendors and partners that have been contracted for clinical trial activities to assess adherence to applicable regulations.
Host and support company regulatory GCP inspections.
Oversee the clinical quality system document control process, including review and approval of controlled documents.
Support concurrent operational efforts by consulting on projects and representing QA in interactions with clients.
Foster an environment that supports compliance and drives continuous improvement activities with emphasis on root cause analysis.
Performs other duties as assigned

A minimum of 10+ years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience.
Extensive knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines.
Focuses on results rather than process and seeks to minimize complexity when process is required

5+ years of experience in a Leadership role at a CRO, biotech, or pharma company.
10+ years of previous related GCP QA experience at a CRO, biotech, or pharma company.
Prior experience working for both a Sponsor company and a CRO.
Early phase clinical trial experience.
CHI: $120,000-$170,000
University/college degree (life science preferred) in a scientific or technical discipline from an appropriately accredited institution.

Provide Executive Management trends and metrics of the clinical QA program and CAPA status, at a minimum of annually.

Drive the strategic vision for the clinical QMS, ensuring robust compliance across all internal systems, pharmaceutical CRO clinical operations, and proprietary medical device sponsored studies.
Never stops learning

This listing is sourced directly from Tempus AI's careers page and normalized into a canonical job model.