Contractual Fda Inspector Jobs in Chicago, IL (NOW HIRING)

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.

This leader will drive complex development programs from concept through launch, partner across R&D and operational functions, and build scalable systems that enable high-quality, inspection-ready product development.

• Lead late-stage development, validation, and launch readiness for molecular diagnostic products, including IVD, CDx, IUO, and LDT programs.
• Provide strategic and scientific leadership for design controls, validation planning and execution, design transfer, and post‑launch changes.
• Serve as a key cross‑functional partner to Regulatory, Quality, Clinical Lab Operations, Bioinformatics, Automation, Program Management, and Pharma Business Development.
• Drive regulatory submission support, including FDA, IVDR, MolDX, NYS, CAP, and other global or regional requirements.
• Oversee documentation strategy and development processes to ensure inspection readiness, consistency, traceability, and scalability.
• Lead complex issue resolution, including deficiency responses, non‑conformances, root‑cause investigations, and scope pivots.
• Advance continuous improvement initiatives across product development, including templates, risk‑based tools, project estimation, change management, and process standardization.
• Support external and partner‑facing development programs, including companion diagnostics and contractual assay development efforts.
• Mentor and develop a high‑performing team of scientists and documentation specialists.
• Contribute to resource planning, budgeting, staffing strategy, and organizational development within R&D.

• PhD with 8+ years of experience or Master’s degree with 13+ years of experience in molecular diagnostics, assay development, or a related life sciences field in a regulated environment.
• Deep experience leading design‑controlled product development for molecular diagnostics or sequencing‑based assays.
• Strong working knowledge of IVD/CDx development, validation, design transfer, and regulatory submissions.
• Demonstrated success working in regulated frameworks including FDA, IVDR, ISO 13485, QMSR, MolDX, and NYS.
• Track record of leading cross‑functional teams through complex technical and regulatory milestones.
• Experience building scalable processes, documentation systems, and development infrastructure in a fast‑paced environment.
• Strong leadership, communication, and organizational skills, with the ability to influence across technical and operational stakeholders.
• Strong people management experience, including hiring, mentoring, and leading teams through growth and change.

• Experience supporting audits, inspections, pre‑submissions, deficiency responses, and approval pathways.
• Experience with companion diagnostic developments, pharma partnerships, and external development programs.
• Experience with automation, LIMS, and 21 CFR Part 11 compliant software tools such as ELNs.

This role is critical to advancing Tempus’ regulated diagnostics portfolio by ensuring products are scientifically robust, operationally scalable, and developed with the rigor required for successful launch, regulatory approval, and long-term platform growth.

Estimated salary range: $173,000–$245,000 (applicable if the role is performed from Illinois; 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.