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Chicago, Illinois, United States
Onsite
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
As the Senior Manager of Quality Assurance (QA), you will report directly to the Director of QA and serve as the operational engine driving the execution, management, and continuous improvement of Tempus’ clinical Quality Management System (QMS). Operating at the intersection of cutting-edge AI and clinical compliance, you will manage day-to-day operations to ensure our systems comply with ICH-GCP and applicable international regulations. This vital role supports quality workflows across both our CRO business for pharmaceutical clients and Tempus’s own sponsored medical device clinical trials.
Key Responsibilities & Core Ownership
Execute Clinical Compliance: Implement and maintain the tactical workflows of the clinical QMS, ensuring measurable compliance across all internal software/hardware systems, pharmaceutical CRO clinical operations, and proprietary medical device sponsored studies.
Support Cross-Functional Teams: Serve as an accessible organizational mentor and hands-on subject matter expert on clinical validation architectures. You will work closely with project teams to guide them through complex compliance ecosystems, fostering a culture of high-velocity education and alignment.
Optimize Team Efficiencies: Take an active, collaborative role in mentoring junior quality staff. Collaborate with the Director of QA to identify structural efficiencies, optimize daily operations, and establish seamless workflows within the team for maximum impact.
Job Responsibilities:
Collaborate 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.
Manage and drive the clinical CAPA and non-conformance programs, ensuring timely root cause analysis and resolution.
Aggregate, track, and provide quality trends and metrics of the clinical QA program and CAPA status to QA Leadership for executive reporting.
Support concurrent operational efforts by consulting on active projects and representing QA in interactions with clients.
Ensure standard operating procedures (SOPs) are kept up to date to reflect current regulations, technological changes, trends, and best practices.
Assist QA Leadership with reports and investigations of suspected research misconduct.
Foster an environment that supports compliance and drives continuous improvement activities with emphasis on root cause analysis.
Keeps current with GCP quality and regulatory surveillance, as well as industry trends, and share information with applicable personnel.
Ensure that clinical trial documentation is in absolute compliance with applicable regulations and standards.
Performs other duties as assigned.
Minimum 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.
Preferred Qualifications:
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.
Prior experience working for both a Sponsor company and a CRO.
Early-phase (Phase I/II) clinical trial experience.
The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.