Director, (GCP) Quality Assurance

Tempus Compass, LLC; Chicago (IL); Hybrid; USD 160,000 - 200,000; Full time

Benefits offered by this job

Benefits package

Hybrid/Remote work

Job summary

Tempus is seeking a Director of Quality Assurance to own and scale the clinical QMS across a global environment. You will ensure compliance with ICH-GCP and FDA-related standards, shaping the QA organization and mentoring cross-functional teams in validation architectures.

You will lead audits, drive CAPA programs, and manage supplier quality frameworks while partnering with executive management to advance quality initiatives and regulatory readiness.

Qualifications

• Must have a strong track record in clinical quality assurance and compliance.
• Extensive knowledge of ICH-GCP guidelines and international regulatory requirements.
• Experience leading QA programs across sponsors, CROs, and device studies.

Responsibilities

• Owns the clinical QMS strategy and scalable QA processes.
• Leads audits of internal, vendor, and site activities to ensure compliance.
• Collaborates with executives and cross-functional leaders to implement quality initiatives.

Skills

Clinical QA leadership

Regulatory knowledge

GCP / ICH-GCP

Quality management

Auditing

Stakeholder leadership

Education

University degree in life science

Tools

QMS platforms

Job description

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 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.

Location

Open to Hybrid in Chicago or Remote candidates

Key Responsibilities & Core Ownership

• Champion Clinical Compliance: 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.
• Empower Cross-Functional Teams: Act as the primary organizational mentor and subject matter expert on clinical validation architectures. You will partner closely with internal leaders to guide them through complex compliance ecosystems, fostering a culture of high-velocity education and alignment.
• Design Team Architecture & Efficiencies: Take an active, entrepreneurial role in shaping our QA organization. Collaborate with key stakeholders to brainstorm structural efficiencies, scale operations, and design how parallel quality roles can best collaborate for maximum impact.
• 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.
• Oversee GCP framework for sponsored clinical trials to ensure required quality elements are strategically executed on, risk-based, as appropriate.
• Oversee the clinical QA audit program, including development and maintenance of the internal, client, and vendor audit schedule.
• Oversee the clinical 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 clinical quality system document control process, including review and approval of controlled documents.
• Oversee the clinical CAPA and non-conformance programs.
• Provide Executive Management trends and metrics of the clinical 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 personnel.
• Ensures that clinical trial documentation is in compliance with applicable regulations and standards.
• Performs other duties as assigned.

Qualifications

• University/college degree (life science preferred) in a scientific or technical discipline from an appropriately accredited institution.
• A minimum of 10+ years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience.
• Drug and/or device clinical trials or 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 the Google platform, Microsoft Word, Excel, and modern electronic QMS/clinical trial platforms.
• Preferred 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: $160,000 - $200,000

The expected salary range may vary for other locations. 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.

Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company’s first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics. We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives.

We're looking for people who can change the world. Who question the status quo and don't shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We're looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.