Director, CRO Quality Assurance (GCP)

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, CRO Quality Assurance (QA) is responsible for the management and oversight of Tempus Compass', our Clinical CRO subsidiary, 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

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$150,000 - $225,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, 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.