Description
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 supporting process, to ensure systems remain in a validated, compliant state in accordance with applicable regulations and SOPs.
• Perform gap assessments and remediation activities, as needed.
• Ensure timely, efficient, and effective communication and interaction with internal GxP partners and external contract providers.
Qualifications
• Bachelor of Science degree in Computer Science, Life Sciences, Engineering, or a similar discipline (or equivalent experience).
• 10+ years of experience in computer system validation activities in the pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• 3+ years in a leadership or people-management capacity, including management of contract CSV personnel (onsite and/or offshore), preferred.
• Demonstrated, senior-level, hands-on experience qualifying and validating GxP-relevant IT infrastructure and enterprise systems, including cloud environments (e.g., AWS), identity and access management systems (e.g., Okta), directory services (e.g., Active Directory), and dedicated computing environments.
• Strong validation experience with infrastructure-adjacent and analytical applications, such as RStudio/Posit, SAS platforms, Pinnacle 21, or similar regulated systems.
• Experience using Veeva Vault Quality, including Veeva Validation Management.
• Proven experience supporting Deviations, Investigations, Change Controls, and CAPA actions within a regulated environment.
• Advanced working knowledge of GxP regulations and approaches to System Life Cycles (SLC) and risk-based validation (e.g., GAMP 5), as well as 21 CFR Part 11, Annex 11, and data integrity (ALCOA+) principles.
• Experience validating Quality, Regulatory, Clinical, or Analytical systems in a pharmaceutical or biotech environment strongly preferred.
• Experience qualifying and validating enterprise IT infrastructure in cloud-based and hybrid environments preferred.
• Experience validating Veeva Vault applications a plus.
• ASQ certification such as CQE or CQM a plus.
Key Competencies
• Strong leadership skills, with the ability to influence, mentor, and guide cross-functional teams.
• Excellent written and oral communication skills, with the ability to clearly convey technical and compliance concepts.
• Strong project-management, planning, organizing, and execution skills, including the ability to manage multiple priorities and meet deadlines.
• Ability to work independently while proactively identifying risks, gaps, and improvement opportunities.
• Detail-oriented mindset, with a strong focus on audit readiness, documentation quality, and regulatory compliance.
• Ability to develop and implement creative solutions to improve processes.
Other Qualifications
• Must support Pacific Time business hours (9 AM to 5 PM PT)
This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based within the continental US. The anticipated salary range for fully qualified candidates applying for this position is $175,000 - $185,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
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