SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 160,000 - 200,000 / annual
Tempus is seeking a Director of Quality Assurance to lead the clinical Quality Management System (QMS) and oversee a growing QA organization. This role sits at the intersection of AI-driven precision medicine and clinical compliance, with responsibility for ensuring Tempus' global systems operate in accordance with ICH-GCP and applicable international regulations.
You will hold ultimate accountability for the strategic oversight and scaling of the clinical QMS across two distinct business lines: Tempus's CRO operations serving pharmaceutical clients and the company's own sponsored medical device clinical trials. This is a high-impact leadership position requiring both operational excellence and deep regulatory expertise.
Key responsibilities include: championing clinical compliance across all internal systems and external partnerships; mentoring cross-functional teams on clinical validation architectures and complex compliance ecosystems; designing team structures and operational efficiencies to scale QA capabilities; collaborating with executive leadership to establish quality goals and ensure adherence to FDA, ICH, and other global regulatory standards; overseeing the GCP framework for sponsored clinical trials; managing the clinical QA audit program (internal, investigator site, and vendor audits); qualifying and maintaining oversight of clinical suppliers and vendors; managing document control, CAPA programs, and non-conformance tracking; providing executive reporting on QA metrics and trends; supporting regulatory inspections; and fostering a culture of continuous improvement and compliance.
Required qualifications: Bachelor's degree in life sciences or related scientific/technical discipline; minimum 10+ years of clinical research experience across research sites, biotech, pharma, or CRO environments; hands-on experience with drug and/or device clinical trials; extensive knowledge of ICH Guidelines and GCP including international regulatory requirements; demonstrated ability to manage competing priorities and build strong relationships with team members and clients; excellent written and verbal communication; strong organizational skills and attention to detail; proficiency with Google platform, Microsoft Office, and modern electronic QMS/clinical trial platforms.
Preferred: 5+ years in a leadership role at a CRO, biotech, or pharma company; 10+ years of GCP QA experience; prior experience at both sponsor and CRO organizations; early-phase clinical trial background.
