Director, (GCP) Quality Assurance

Tempus AI•Chicago, IL

2d•Hybrid

About The Position

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. This high-impact role uniquely oversees both our CRO business for pharmaceutical clients and Tempus’s own sponsored medical device clinical trials.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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 upon, 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