Facilities Compliance Lead

Caris Life Sciences • Phoenix, AZ

21h

About The Position

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary The Facilities Compliance Lead oversees the processes, documentation, training, and Commissioning, Qualification, and Validation (CQV) activities for Facilities, Utilities, and Equipment (FUE) within a life sciences environment. This includes office spaces, laboratories, GMP manufacturing areas, and research facilities. The role integrates clear, well-defined processes with effective training methods to ensure regulatory compliance, operational readiness, and alignment with organizational goals across all regulated and non-regulated Facilities programs.

Requirements

• Bachelor’s degree in Business, Engineering, Science, or a related discipline.
• 7+ years of experience in quality, CQV, and/or compliance program management within life sciences, pharmaceutical, or biotechnology environments, including direct engagement with external auditors.
• Strong knowledge of GMP, laboratory operations, and regulated Facilities, Utilities, and Equipment (FUE) requirements.
• Solid understanding of compliance expectations across the full facility and equipment lifecycle, including documentation, qualification, validation, and change control.
• High proficiency in process mapping and workflow optimization.
• Excellent leadership, communication, collaboration, and strategic planning abilities.
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.

Nice To Haves

• Master’s degree in Business, Engineering, Science, or a related discipline.
• Six Sigma training and Green Belt Certification

Responsibilities

• Compliance Program Management: Develop and manage a portfolio of CQV focused Facilities, Utilities, Equipment (FUE) compliance projects that support lifecycle management and strategic organizational initiatives. Align CQV and FUE lifecycle compliance objectives with corporate priorities, operational needs, and scientific workflows. Establish governance frameworks, reporting structures, and risk-based validation strategies to ensure effective oversight of CQV and FUE programs. Define and maintain standards for developing, executing, and controlling CQV and FUE lifecycle documentation, including specifications, protocols, reports, and change controls. Monitor CQV and FUE program performance metrics and ensure all facilities personnel maintain a strong understanding of regulatory expectations throughout the asset and process lifecycle.
• Project Management: Plan and execute CQV driven Facilities, Utilities, and Equipment (FUE) lifecycle projects from concept and design through commissioning, qualification, validation, and final completion. Collaborate with technical SMEs and cross-functional stakeholders to ensure lifecycle deliverables meet both technical requirements and CQV/regulatory compliance expectations. Manage project budgets, schedules, communications, financial reporting, and vendor contracts to support successful delivery of FUE CQV activities across the asset and process lifecycle.
• Regulatory and Compliance Oversight: Ensure adherence to FDA, GMP, ISO, OSHA, CAP, CLIA and other applicable regulatory standards across all Facilities, Utilities, and Equipment (FUE) lifecycle activities. Develop and maintain documentation, SOPs, and training materials to ensure alignment with regulatory expectations and consistent employee adherence. Ensure all CQV and FUE compliance efforts are fully aligned with the Caris Quality Management System (QMS), including required protocols and documentation controls. Provide ongoing updates and training in response to changes in processes, protocols, and regulations to maintain continual compliance and operational readiness. Serve as the subject matter expert (SME) for internal and external audits, supporting audit preparation, execution, responses, and remediation for all FUE CQV-related areas.
• Stakeholder Engagement: Serve as the primary liaison between Facilities, Utilities, and Equipment (FUE) teams, research groups, executive leadership, Quality, and external contractors for all CQV and compliance-related activities. Clearly and succinctly communicate new initiatives, lifecycle processes, and program impacts to ensure stakeholders at all levels remain engaged, informed, and aligned. Provide transparent and timely communication regarding program status, risks, issues, and key milestones to support effective decision-making and oversight. Conduct meetings and presentations with clarity and confidence, ensuring effective communication of information to diverse audiences.
• Risk and Quality Management: Perform comprehensive risk identification, analysis, and mitigation across the CQV/FUE program portfolio, applying a structured risk-based approach to prioritize activities, allocate resources, and ensure compliant lifecycle outcomes. Ensure quality standards, commissioning/qualification requirements, and validation expectations are met for all facilities by integrating risk assessments into planning, design, execution, and change control processes. Conduct ongoing, risk-focused audits of processes, documentation, and lifecycle deliverables to confirm continued compliance, identify gaps, and drive timely corrective and preventive actions (CAPA).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees