GxP Systems Administrator

Location Redwood City, CA - Hybrid Role Job Summary The GxP Systems Administrator will be responsible for the day-to-day support and administration of application platforms that enable our Research & Development (R&D) functions. The ideal candidate will have hands-on experience administering GxP-compliant SaaS systems, with a focus on user management, system access, and operational support, along with a strong understanding of regulatory requirements in a life sciences environment. Duties and Responsibilities Administer and support GxP systems that enable R&D functions in compliance with applicable regulations and standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5). Manage user access for GxP (and occasionally non-GxP) R&D platforms, including provisioning, modifying, and deactivating user accounts. Troubleshoot and resolve support requests and incidents related to GxP systems in a timely and precise manner. Collaborate with cross-functional teams (e.g., Quality, Regulatory, Clinical, IT) to support business operations and ensure compliance. Perform routine system activities such as periodic user access reviews, audit trail reviews, and other steady?state tasks per company procedures and regulatory standards. Support the implementation and maintenance of new GxP systems, including validation activities and system documentation (e.g., specifications, user guides, administration procedures). Requirements and Qualifications Bachelors degree or equivalent in a relevant field (e.g., Information Technology, Computer Science) with experience supporting GxP-regulated environments, in pharma, life sciences, or related industries. Direct experience administering GxP quality and regulatory platforms. Basic understanding of industry guidelines (GAMP 5) and US/international regulations (FDA, ICH, ISO, EU) for GxP systems. Knowledge of user management, including security access controls, policies, and permissions. Experience providing system support, including troubleshooting and resolving user issues. Efficient time management, with the ability to support multiple systems simultaneously. Strong written and verbal communication skills and the ability to present complex information. Ability to work effectively in a dynamic and fast-paced environment. Preferred Qualifications Veeva Vault White Belt certification or 2+ years' experience configuring Veeva Vault systems. Direct experience administering and configuring Veeva Vault (Quality, RIMS), eTMF (Trial Interactive), DocuSign Part 11, and Lorenz DocuBridge. In-depth understanding of Computer System Validation (CSV) principles, Software Development Life Cycle (SDLC) processes, and 21 CFR Part 11 compliance, with applied experience in validation documentation and ensuring regulatory adherence. Familiarity with Azure Entra and Active Directory. Basic scripting or automation skills (e.g., Python, PowerShell) to support system efficiency. Experience collaborating with Quality and Regulatory teams within a GxP environment. Desired Skills and Experience GxP Systems Administration, Research & Development Systems Support, 21 CFR Part 11 Compliance, Annex 11 Compliance, GAMP 5, User Access Management, System Access Control, Security Permissions Management, SaaS Platform Administration, Troubleshooting, Incident Resolution, Cross-functional Collaboration, Audit Trail Review, User Access Reviews, System Validation, Validation Documentation, System Documentation, Quality Platform Administration, Regulatory Platform Administration, FDA Regulations, ICH Guidelines, ISO Standards, EU Regulations, Computer System Validation (CSV), Software Development Life Cycle (SDLC), Veeva Vault Administration, Veeva Vault Configuration, Veeva Quality, Veeva RIMS, eTMF Administration, Trial Interactive, DocuSign Part 11, Lorenz DocuBridge, Azure Entra, Active Directory, Python, PowerShell, Scripting, Automation, Life Sciences Industry, Pharmaceutical Industry, Technical Documentation, Compliance Management, Regulatory Adherence, System Implementation, Business Operations Support. Employment Type Contract Seniority level Mid?Senior level Job Function Information Technology and Science Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com. #J-18808-Ljbffr