Senior Manager, IT Qualification & Validation

Arcus Biosciences is seeking an experienced Senior Manager, IT Qualification & Validation to join our dynamic and collaborative team.  This is an opportunity to make a meaningful difference in a growing, fast-paced, clinical-stage organization.  In this role, you will provide senior-level leadership and hands-on expertise across the qualification and validation of GxP-regulated computerized systems and IT infrastructure throughout the computerized system lifecycle, ensuring compliance with applicable regulatory requirements, Computer Systems Validation (CSV) and lifecycle procedures, and data integrity principles.  You will plan, author, implement, and maintain validation for the business and infrastructure systems supporting regulated (GxP) activities, while leading and developing contract CSV resources and continuously enhancing the Arcus validation program.  The ideal candidate brings enterprise-level, hosted-application and infrastructure qualification experience, combined with proven people-leadership and project-management skills.

Summary

The Senior Manager, IT Qualification & Validation serves as both a people leader and a technical and compliance subject matter expert (SME).  Collaborating closely with IT, Quality, and business stakeholders, this individual will define qualification and validation strategies, oversee and execute qualification and validation activities, and ensure that qualified and validated systems remain compliant throughout their lifecycle.  The role places strong emphasis on infrastructure qualification, dedicated computing environments, and regulated analytical platform validation, while also managing contract CSV resources, supporting Quality Systems, and driving inspection readiness.

Responsibilities

•       Lead, mentor, and manage contract CSV resources (onsite and offshore), including assigning projects, obtaining status reports, providing technical and procedural guidance, and approving timesheets.

•       Plan and organize validation activities across cross-functional groups; provide and maintain status updates for activities related to day-to-day operations and project work.

•       Collaborate with IT leadership and Quality to define resource allocation, validation scope, and validation timelines.

•       Generate, obtain approvals for, and execute validation deliverables for computerized systems and supporting infrastructure – including Validation Plans, Test Plans, User and Functional Requirements, Installation/Operational/Performance Qualification (IQ/OQ/PQ) test scripts, Traceability Matrices, Test Summary Reports, and Validation Summary Reports – ensuring documents meet the regulatory and procedural requirements of 21 CFR Part 11, Annex 11, data integrity, and GAMP 5, among others.

•       Lead and execute senior-level infrastructure qualification and validation activities for GxP-relevant systems, including but not limited to Okta Single Sign-On, Active Directory, Amazon Web Services (AWS), dedicated computing environments, and infrastructure-related GxP applications.

•       Provide validation oversight and support for infrastructure-related and analytical platforms (e.g., RStudio/Posit, SAS environments, Pinnacle 21, and similar systems).

•       Perform hands-on execution of qualification and validation testing, including authoring and execution within Veeva Validation Management (VVM).

•       Support and, where required, lead validation activities within Veeva Vault Quality, including test script authoring/execution and lifecycle maintenance.

•       Support change control activities to ensure validation impact assessments are performed in a compliant manner and that regulated systems are maintained in a validated state.

•       Support Deviation, Investigation, and CAPA activities, including impact assessments, root cause analysis, remediation planning, and documentation.

•       Work with QA to investigate system issues, perform root cause analysis, and implement solutions.

•       Develop and enhance the Arcus validation program to ensure ongoing alignment with regulatory expectations.

•       Conduct periodic reviews of GxP computerized systems, and maintain the s