GxP IT Validation Lead

Role overview Lead hands-on validation work for computerized systems used in regulated life sciences environments, helping clients establish and maintain a documented, inspection-ready state. You’ll determine proportionate, risk-based approaches, prepare and execute validation deliverables, and coordinate closely with client Quality Assurance (QA), system owners, IT teams, and specialists. Client QA retains approval authority; this role leads execution and makes recommendations supported by clear technical reasoning.

Responsibilities - Define intended use, system boundaries, GxP impact, and validation scope with QA and system owners. - Author and execute validation plans, requirements, risk assessments, test protocols, traceability records, and reports. - Assess regulated SaaS, cloud applications, collaboration platforms, and supporting infrastructure; plan qualification with technical specialists where needed. - Maintain system inventories and validation status, and assess changes, vendor releases, and periodic review needs. - Evaluate controls for electronic records and signatures, access, audit trails, retention, and data integrity. - Prepare evidence for audits and inspections, track remediation, and improve templates and delivery methods.

Requirements - Substantial hands-on GxP computerized system validation or IT quality experience in life sciences; demonstrated delivery capability is central. - Experience owning validation work from document preparation and testing through QA review and completion. - Practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ data integrity principles, and risk-based validation approaches. - Experience with regulated SaaS, cloud-hosted applications, or other computerized systems, including awareness of supporting infrastructure and shared responsibilities. - Experience maintaining validated systems through change control, release assessment, or periodic review. - Strong technical writing, client communication, and organization skills; able to manage concurrent assignments and support audit or inspection requests. - U.S. work authorization and residence in the United States.

Nice to have Consulting or managed-services experience, infrastructure qualification, familiarity with Microsoft 365, SharePoint, Azure, or comparable regulated platforms, direct health-authority inspection experience, SOX ITGC or SOC 2 familiarity, and experience estimating work or mentoring colleagues.

Benefits and work setup The work is client-facing and coordinated with IT engineers, compliance staff, and specialists. Client QA approves validation deliverables and GxP change decisions; responsibilities are assigned to preserve independence, and work is matched to demonstrated competence.