Tempus AI
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Director, Quality Assurance (GCP)
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Tempus AI 1 day ago Be among the first 25 applicants Join to apply for the
Director, Quality Assurance (GCP)
role at
Tempus AI 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.
The Director, Quality Assurance (QA) is responsible for the management and oversight of Tempus Compass’ Quality Management System (QMS) and QA program. This role is responsible for assessing Tempus Compass’ systems to ensure the organization operates in accordance with the standards of ICH-GCP and applicable GCP regulations.
Job Responsibilities
Collaborate with Executive Management to lead, implement, and continuously improve the QMS for Compass, establishing quality goals and initiatives, and ensuring compliance to applicable global regulations and standards, such as FDA and ICH. Oversee the Compass QA audit program, including development and maintenance of the internal, client, and vendor audit schedule. Oversee the Compass supplier/vendor quality qualification framework and approved vendor list. 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. Conduct audits, including Internal, Investigator Site and Trial Master File. Host and support company regulatory GCP inspections. Oversee the quality system document control process, including review and approval of Compass controlled documents. Oversee the Compass CAPA and non-conformance programs. Provide Executive Management trends and metrics of the Compass QA program and CAPA status, at a minimum of annually. Support concurrent operational efforts by consulting on projects and representing QA in interactions with clients. Ensure standard procedures are updated to reflect current regulations, technological changes, trends, and best practices. Assist with reports of suspected research misconduct investigation. 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 trends, and shares information with applicable Compass personnel. Ensures that clinical trial documentation is in compliance with applicable regulations and standards. Performs other duties as assigned
Demonstration Of Tempus Compass Values
Consistently strives to demonstrate the following Tempus Compass values:
Recognizes that the team is always stronger than the individual Seeks to inspire others by demonstrating consistently strong performance Treats people with respect regardless of role or point of view Listens well and seeks to understand before reacting Provides candid, helpful, and timely feedback to colleagues in line with GCP quality concepts and best practices Demonstrates curiosity about and contributes effectively to areas outside of their specialty Keeps the bigger picture in mind when making decisions Never stops learning Questions assumptions and offers suggestions for improvement Focuses on results rather than process and seeks to minimize complexity when process is required Identifies and addresses root causes, not symptoms Demonstrates poise in stressful situations Strives to always do the right thing Questions actions that are incongruent with Compass values
Minimum Qualifications
University/college degree (life science preferred) in a scientific or technical discipline from an appropriately accredited institution A minimum of ten (10) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience Oncology clinical trials or oncology clinical 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 Demonstrated ability to build rapport with team members and clients Excellent written and verbal communication skills Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines Able to proactively anticipate needs and follow through on all assigned tasks Proficient in Microsoft Word and Excel
Preferred Qualifications
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
$150,000 - $225,000
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.
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Seniority level Director Employment type
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Director, Quality Assurance (GCP)
role at
Tempus AI 1 day ago Be among the first 25 applicants Join to apply for the
Director, Quality Assurance (GCP)
role at
Tempus AI 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.
The Director, Quality Assurance (QA) is responsible for the management and oversight of Tempus Compass’ Quality Management System (QMS) and QA program. This role is responsible for assessing Tempus Compass’ systems to ensure the organization operates in accordance with the standards of ICH-GCP and applicable GCP regulations.
Job Responsibilities
Collaborate with Executive Management to lead, implement, and continuously improve the QMS for Compass, establishing quality goals and initiatives, and ensuring compliance to applicable global regulations and standards, such as FDA and ICH. Oversee the Compass QA audit program, including development and maintenance of the internal, client, and vendor audit schedule. Oversee the Compass supplier/vendor quality qualification framework and approved vendor list. 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. Conduct audits, including Internal, Investigator Site and Trial Master File. Host and support company regulatory GCP inspections. Oversee the quality system document control process, including review and approval of Compass controlled documents. Oversee the Compass CAPA and non-conformance programs. Provide Executive Management trends and metrics of the Compass QA program and CAPA status, at a minimum of annually. Support concurrent operational efforts by consulting on projects and representing QA in interactions with clients. Ensure standard procedures are updated to reflect current regulations, technological changes, trends, and best practices. Assist with reports of suspected research misconduct investigation. 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 trends, and shares information with applicable Compass personnel. Ensures that clinical trial documentation is in compliance with applicable regulations and standards. Performs other duties as assigned
Demonstration Of Tempus Compass Values
Consistently strives to demonstrate the following Tempus Compass values:
Recognizes that the team is always stronger than the individual Seeks to inspire others by demonstrating consistently strong performance Treats people with respect regardless of role or point of view Listens well and seeks to understand before reacting Provides candid, helpful, and timely feedback to colleagues in line with GCP quality concepts and best practices Demonstrates curiosity about and contributes effectively to areas outside of their specialty Keeps the bigger picture in mind when making decisions Never stops learning Questions assumptions and offers suggestions for improvement Focuses on results rather than process and seeks to minimize complexity when process is required Identifies and addresses root causes, not symptoms Demonstrates poise in stressful situations Strives to always do the right thing Questions actions that are incongruent with Compass values
Minimum Qualifications
University/college degree (life science preferred) in a scientific or technical discipline from an appropriately accredited institution A minimum of ten (10) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience Oncology clinical trials or oncology clinical 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 Demonstrated ability to build rapport with team members and clients Excellent written and verbal communication skills Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines Able to proactively anticipate needs and follow through on all assigned tasks Proficient in Microsoft Word and Excel
Preferred Qualifications
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
$150,000 - $225,000
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.
Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Quality Assurance Referrals increase your chances of interviewing at Tempus AI by 2x Get notified about new Director of Quality Assurance jobs in
Chicago, IL . Chicago, IL $170,000.00-$230,000.00 1 week ago Director, Industrial Food Safety & Quality Audit
Chicago, IL $127,577.00-$170,102.00 2 weeks ago Downers Grove, IL $62,000.00-$66,000.00 1 month ago Alsip, IL $75,000.00-$100,000.00 6 days ago Senior Food Safety Quality Assurance Manager
Director, Quality Assurance and Accountability (QAA)
Chicago, IL $115,000.00-$125,000.00 2 days ago Harwood Heights, IL $100,000.00-$100,000.00 1 month ago Regional Food Service Director of Operations
Oak Brook, IL $127,000.00-$216,000.00 2 months ago Sr. Director, Product Management, Developer Experience - Quality Assurance
Director of Manufacturing: Midwest/MidAtlantic
Regional Director of Operations - MidWest
Lombard, IL $130,000.00-$140,000.00 1 month ago Regional Technical Director Chemistry - North America
Mgr of Quality Bone Marrow Transplant - Hybrid-18918
Project Director Workforce Supports (44053)
Quality Manager (Heavy Civil Construction)
Des Plaines, IL $99,756.00-$149,633.00 2 weeks ago Chicago, IL $175,000.00-$200,000.00 1 week ago Associate Director, Volunteer Communications & Marketing
Director of Nursing and Clinical Services
Chicago, IL $105,000.00-$140,000.00 1 month ago Associate Director, Volunteer Communications & Marketing
Glenview, IL $120,542.72-$156,710.84 4 weeks ago Clinical Director, Speech Language Pathology (CCC-SLP)
Chicago, IL $75,000.00-$96,000.00 2 days ago Chicago, IL $90,000.00-$105,000.00 1 hour ago Clinical Director, Speech Language Pathology (CCC-SLP)
Chicago, IL $75,000.00-$96,000.00 4 days ago Chicago, IL $157,000.00-$200,000.00 6 days ago Program Director of Behavioral Health Services
Chicago, IL $90,000.00-$100,000.00 4 days ago Des Plaines, IL $100,000.00-$100,000.00 4 days ago Advanced Rail Technology, Director of Engineering - Uptime
SENIOR MANAGER OF COMPLEX CARE COORDINATION - HEALTH PLAN SERVICES
Chicago, IL $80,000.00-$83,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr