Hiring: Sr. Manager, Quality Assurance Company: Tempus AI Location: Chicago, IL Job Posted Time: 2026-09-03 10:20:56 Target Skills & Keywords : GCP About the job Experience: •8+ years of relevant clinical research experience in a combination of research site, biotech/pharma, or CRO environments. •2+ years of experience in a people-management, project-lead, or supervisory quality role at a CRO, biotech, or pharma company. •6+ years of previous GCP QA auditing experience at a CRO, biotech, pharma, or medical device company. Required Skills: •Partner cross-functionally with the Director of QA to implement, maintain, and continuously improve the clinical QMS, executing quality initiatives and ensuring day-to-day compliance with applicable global regulations and standards, such as FDA and ICH. •Collaborate cross-functionally to ensure the GCP framework for sponsored clinical trials is executed according to global regulatory requirements and Tempus’ QMS. •Manage the day-to-day operations of the clinical QA audit program, including the practical execution and scheduling of internal, client, and vendor audits. •Manage the clinical supplier/vendor quality qualification framework and maintain the approved vendor list. •Conduct qualification and ongoing audits of vendors and partners that have been contracted for clinical trial activities to assess adherence to applicable regulations. •Directly conduct audits, including Internal, Investigator Site, and Trial Master File (TMF) audits. •Provide vital operational support during company regulatory GCP inspections and client audits. •Manage the clinical quality system document control process, including the hands-on review and processing of controlled documents. Qualifications: •University/college degree (life science preferred) in a scientific or technical discipline from an appropriately accredited institution. •A minimum of 6–8+ years of relevant clinical research experience in a combination of research site, biotech/pharma, or CRO environments. •Direct experience with drug and/or medical device clinical trials or clinical data. •Strong, practical working knowledge of ICH Guidelines and GCP, including international regulatory requirements for the conduct of clinical development programs. •Demonstrated ability to manage multiple competing priorities and utilize resources effectively. •Demonstrated ability to build rapport with team members, cross-functional partners, and external clients. •Excellent written and verbal communication skills. •Excellent organizational skills, rigorous attention to detail, and the ability to adapt to changing priorities within tight timelines. •Able to proactively anticipate operational needs and follow through on all assigned tasks. •Proficient in the Google platform, Microsoft Word, Excel, and modern electronic QMS/clinical trial platforms. Compensation: •$100,000 - $160,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!