Caris Life Sciences

QA Engineer

• Lead the Design Controls planning and maintain the Design history file (DHF).
• Ensure compliance with all applicable regulations.
• Collaborate with cross-functional teams throughout the product lifecycle.
• Support management reviews and audits related to Design Controls and Risk Management.
• Create and maintain risk management file with support from cross-functional teams.
• Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications.
• Manage deviation and issues for verification and validation activities.
• Support design reviews and transfer activities including process validations, pFMEA and DMR.
• Perform risk assessments for regulatory submissions.

Staff Design Quality Engineer

Support Engineer

• Provide exceptional customer service and support keeping communications fluid throughout the support and troubleshooting.
• Ability to effectively configure, support, troubleshoot and prioritize all service requests and incidents.
• Provide accurate and detailed documentation in ServiceNow ITSM Suite of incidents and problems, including the steps taken during the analysis and resolution/restoration process in ServiceNow.
• Assist in building and maintaining architectural runbooks, hardware, and software refresh lifecycle, and maintenance and support contracts.
• Answer questions surrounding the installation, usage, and training of hardware and software products.
• Possess the ability to learn on the job, especially software applications that you may not be familiar with or use every day.
• Ability to shift between projects/tasks to keep up with the workload.
• Regularly update customers on open issues providing ETA of resolution.
• Assist other members of the Information Services department with hardware/software/network technical assistance as needed.
• Timely acknowledgment and triage of service management incidents to determine the proper impact and urgency to recovery and prevent system outages leveraging and updating knowledgebase articles.
• Participate in occasional off-hours work such as installations, and in regular on-call rotation for off-hours outages and escalations.
• Serve as the team Lead when the Lead is unavailable.
• Coordinate and drive processes to identify operational problems with assigned systems and provide technical support to resolve them promptly.
• Ability to transition between supporting different platforms such as lab operations, AV, smart hands for networking and telecom as well as cloud hosted environments.

Technical Support Specialist II

Manager

• Lead IVD/CDx clinical programs.
• Contribute to cross-functional strategy and program planning scenarios.
• Proactively identify, track, manage and resolve clinical program risks and issues.
• Clinical study representative for project and study teams.
• Facilitate internal and external clinical study preparation and planning meetings.
• Collaborate and communicate with study personnel and stakeholders.
• Ensure study protocol, GCP, regulatory and SOP compliance.
• Participate in clinical site assessment, selection, qualification, initiation and closeout processes.
• Provide clinical study site oversight.
• Create and maintain study-specific and trial master files.
• Contribute to and/or lead process improvements.
• Socialize regulatory requirements and standards (e.g., FDA, ICH GCP, ISO 20916, IVDR, MDCG) with cross-functional teams and study personnel.
• Accepts other duties as assigned.

Global Companion Diagnostics Manager

Operations

• Own and manage the end-to-end lifecycle of assigned cases, ensuring accuracy, completeness, and timely progression from order submission through result delivery.
• Review, verify, and validate test orders, requisitions, and supporting documentation; proactively identify and resolve discrepancies or missing information.
• Coordinate with physicians, clinic staff, pathology teams, and internal departments to obtain clarifications and required documentation to maintain workflow continuity.
• Monitor case status, identify risks or potential delays, and implement corrective actions to protect turnaround time, quality, and case integrity.
• Serve as a subject matter expert on ordering requirements, workflow standards, and best practices for Caris testing.
• Submit required reports and documentation accurately and within established timelines.
• Develop and maintain working knowledge of Caris products, services, molecular profiling solutions, technology platforms, reimbursement processes, and billing workflows.
• Partner with physicians and clinical staff to support efficient order submission, adherence to testing requirements, and proper documentation.
• Provide guidance on clinical portals, EMR workflows, and documentation standards.

Embedded Operations Manager

Compliance

• Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
• Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
• Prepare documents necessary for new product market clearance, approval, and continuance during product life cycle management.
• Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions.

Manager – Regulatory Affairs

Director

• Own and manage executive-level relationships within strategic accounts, including CEOs, CMOs, COOs, CFOs, Cancer Center Directors, laboratory leadership, and health system administrators
• Develop, execute, and maintain enterprise-level account strategies spanning surgical workflows, pathology operations, and oncology care delivery
• Identify opportunities to integrate Caris molecular profiling and precision oncology solutions into clinical pathways, institutional standards of care, and system-wide protocols
• Lead Quarterly Business Reviews (QBRs) focused on performance, utilization trends, outcomes, and future growth initiatives
• Analyze account- and regional-level data to identify growth opportunities, adoption barriers, and productivity gaps
• Serve as a strategic partner to Regional Business Directors by aligning enterprise priorities with regional planning, prioritization, and tactical execution
• Provide indirect leadership, mentorship, and subject matter expertise to Oncology Account Executives, Oncology Case Managers, and supporting field roles
• Serve as the primary project owner for strategic initiatives, including complex account onboarding, precision medicine program launches, pathology-driven initiatives, workflow optimization, EMR integrations, and service improvements
• Coordinate cross-functional execution across Operations, Client Services, Laboratory, Medical Affairs, IT, and Marketing to ensure successful delivery of enterprise initiatives
• Define project scope, timelines, deliverables, and success metrics; track progress using CRM and project management tools
• Support new business development and account expansion by assisting with complex deal strategy, value positioning, and navigation of institutional decision-making processes
• Serve as a senior escalation point for strategic accounts and ensure alignment between customer expectations and Caris operational performance
• Represent Caris Life Sciences at the highest levels of customer leadership as a long-term precision medicine partner

Director – Strategic Accounts

• Serving as the SME for Caris’ assays, data and product offerings.
• Inform and design database queries to support feasibility assessments for fit-for-purpose partnership scopes – both for Caris’ core BioPartnering Solutions, and the Strategic Data Business Unit.
• Support the development and execution on account plans and strategy for engaging accounts across the product lifecycle, including preparing content and supporting meetings for high quality external interactions.
• Lead Caris’ biopharma projects by working closely with cross-functional teams internally or externally, including but not limited to Alliance Management, Clinical Research Operations, Cognitive Computing, Medical Affairs, Bioinformatics, Molecular Science Liaison, Molecular Genetics, Pathology, etc.
• Lead, manage and execute biopharma partners RWD research projects assigned by team leadership by collaborating with a team data scientists to deliver aggregated insights to support partners’ clinical programs; apply knowledge of cancer biology, molecular genetics, and clinical oncology to ensure the quality of the projects.
• Communicate effectively with internal and external stakeholders including biopharma partners and/or Caris leadership to formulate and refine research ideas, project scope and partnership proposals to maximize impact to advancing precision oncology.
• Contribute as a member of the cross-functional and heavily matrixed Strategic Data Business Unit (SDBU) organization.

Director – BioPartnering Solutions

Product Marketing

• Lead development and execution of the integrated marketing plan for ChromoSeq in alignment with portfolio strategy and commercial objectives.
• Support annual marketing planning, budget input, and campaign prioritization.
• Conduct market, customer, and competitive analyses to identify growth opportunities and inform positioning strategies.
• Translate market insights into actionable campaigns and targeted initiatives.
• Develop clinically accurate, differentiated messaging that supports ChromoSeq positioning within myeloid malignancy diagnostics.
• Ensure consistency of messaging across campaigns, sales materials, digital content, and conference presence.
• Oversee development of marketing collateral, including sales tools, brochures, white papers, digital content, website updates, and promotional materials.
• Partner with Medical Affairs to ensure scientific accuracy and regulatory alignment.
• Support identification and engagement of key opinion leaders in hematology and oncology in collaboration with Medical Affairs.
• Assist in planning advisory boards, educational programs, and scientific exchange initiatives.
• Partner with Sales Leadership to develop training materials, messaging guides, and campaign tools to enhance field effectiveness.
• Provide ongoing updates to commercial teams on product positioning and competitive landscape insights.
• Track campaign performance, adoption metrics, and customer engagement indicators.
• Analyze data to refine targeting, messaging, and tactical deployment.
• Provide regular reporting and recommendations to marketing and commercial leadership.

Senior Manager – Product Marketing, Caris ChromoSeq

Auditor

• Lead and execute risk-based IT and integrated audit engagements, including SOX IT General Controls (ITGCs), operational, and compliance audits • Serve as a key contributor to the Company’s SOX IT compliance program, including walkthroughs, documentation, and control testing • Develop and maintain audit documentation such as process narratives, risk and control matrices, audit programs, and workpapers • Identify control gaps, assess root causes, and partner with management on remediation plans • Perform operational and integrated audits to assess process efficiency and policy compliance • Coordinate with external auditors and internal stakeholders to support audit requests • Communicate audit results through clear written reports and presentations • Track audit issues and remediation status and escalate as needed • Support annual audit planning and IT risk assessment activities • Leverage data analytics and emerging technologies to enhance audit effectiveness

Senior IT Internal Auditor

• Lead and execute risk-based and integrated audit engagements, including SOX, operational, and compliance audits.
• Serve as a key contributor to the Company’s SOX compliance program, including walkthroughs, design & documentation, and control testing.
• Develop and maintain audit documentation such as process narratives, risk and control matrices, audit programs, and workpapers.
• Identify control gaps, assess root causes, and partner with management on remediation plans.
• Perform operational and integrated audits to assess process efficiency and policy compliance.
• Coordinate with external auditors and internal stakeholders to support audit requests.
• Communicate audit results through clear written reports and presentations.
• Track audit issues and remediation status and escalate as needed.
• Support annual audit planning and risk assessment activities.
• Leverage data analytics and emerging technologies to enhance audit effectiveness.

Senior Internal Auditor – Dallas, Phoenix

Marketing

• Develop and execute strategic marketing initiatives to support international growth
• Manage multiple projects simultaneously
• Contribute to the development and execution of country-specific marketing plans
• Support creation and adaptation of product portfolio content
• Manage international conferences and events
• Prepare and equip distributor teams with enablement tools
• Maintain international marketing campaign calendar and track project timelines

International Marketing Manager

• Responsible for creating the Design and Development Plan (DDP) for the new development projects, updating the DDP throughout the lifecycle of the product.
• Create and maintain risk management file with support from cross-functional teams including risk management plan/report, hazard analysis, dFMEA, uFMEA.
• Provide mentorship, guidance and training to the product development teams new to design controls and risk management processes.
• Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications.
• Manage deviation and issues for the verification and validation activities.
• Support design reviews and design transfer activities including process validations, pFMEA and DMR.
• Support design changes and post market activities, for example deviations and corrective and preventive actions (CAPA) to ensure product safety.
• Perform risk assessments for the regulatory submissions.
• Support the implementation of eQMS tools for design controls and risk management (eDHF).
• Support Management reviews and internal/external audits as a subject matter expert.
• Participate in process improvement initiatives as necessary, performing gap analysis.
• Perform complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management.

Solutions Engineer

• Install back-end, automated data integrations to customer electronic medical records, billing, data warehouses or other applicable customer systems.
• Create, manage, and optimize ETL from multiple internal data systems to provide a foundation for internal analytic dashboards.
• Lead data discovery and validation projects to ensure accurate data is delivered in a timely manner for business users.
• Bridge the gap between business and technology by leading technical requirements gatherings and establishing integration approaches for each unique project.
• Clearly communicate technical processes to non-technical business leaders and non-technical business requirements to technical process owners.
• Assemble large data sets of clinical outcomes.
• Gather business requirements and work with users in an agile fashion to build dashboard outputs based on ETL sourced data.
• Establish access to electronic medical records across multiple platforms using FHIR, HL7, API, or other methods.
• Adhere to documented departmental and corporate standards.

Staff Design Quality Engineer

Technical Support Specialist II

Global Companion Diagnostics Manager

Embedded Operations Manager

Manager – Regulatory Affairs

Director – Strategic Accounts

Director – BioPartnering Solutions

Senior Manager – Product Marketing, Caris ChromoSeq

Senior IT Internal Auditor

Senior Internal Auditor – Dallas, Phoenix

International Marketing Manager

Staff Design Quality Engineer

Data Integration Engineer