GxP IT Validation Lead

Our IT Services practice provides managed IT, cybersecurity, and regulated-industry compliance services to life sciences and biotech companies, from seed stage through public companies. We help clients implement technology, operate it reliably, and demonstrate that the controls supporting regulated work are effective. We are looking for an experienced, hands-on GxP IT validation professional who can lead validation engagements and help clients keep computerized systems in a validated, inspection-ready state. You will personally scope, write, execute, and document risk-based validation work for SaaS and cloud applications, computerized systems, and supporting IT infrastructure. Client QA retains approval authority for validation deliverables and GxP change decisions. This role offers a path toward broader technical and practice leadership as the service grows.

Responsibilities

Define intended use, system boundaries, GxP impact, and risk-based validation scope with client QA and system owners; Prepare and execute validation plans, requirements, risk assessments, test protocols, traceability records, and summary reports; Apply risk-based CSV and applicable computer software assurance principles; Assess SaaS and cloud systems used in regulated work, such as eQMS, eSignature, LIMS, eTMF, and document management platforms; Assess Microsoft 365 or SharePoint configurations for GxP records or workflows; Plan and document qualification of supporting IT infrastructure in collaboration with technical specialists; Explain validation decisions and resolve review comments with client QA; Maintain system inventories, validation status records, and scheduled review activities; Assess changes, vendor releases, and system updates for GxP impact; Perform or coordinate periodic reviews, supplier assessments, and audit trail reviews; Assess electronic record and signature controls, access management, audit trails, retention, and data integrity; Identify gaps, document risks, and track agreed remediation actions; Prepare validation records and IT control evidence for QA reviews, audits, and regulatory inspections; Support responses to observations and follow remediation actions through closure; Escalate compliance concerns, delivery constraints, and unresolved risks promptly; Maintain SOPs, templates, and validation methods; Estimate effort for validation engagements with practice leadership; Coordinate assigned work with IT engineers, compliance staff, and specialist consultants; Provide technical guidance and review work within your area of expertise; Help train IT staff on GxP procedures; Track delivery effort and identify opportunities to improve quality and efficiency

Requirements

Substantial hands-on experience in GxP computerized system validation or IT quality within life sciences; Personal ownership of validation engagements, including authoring deliverables, executing or coordinating testing, resolving QA comments, and completing approved validation packages; Practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles including ALCOA+, and risk-based validation and assurance methods; Experience validating regulated SaaS, cloud-hosted applications, or other computerized systems, with an understanding of the supporting IT infrastructure and shared responsibilities; Ability to distinguish GxP impact, intended use, and system risk, and translate those judgments into a justified validation approach; Experience maintaining validated systems through change control, release assessments, or periodic reviews; Experience supporting a QA review, sponsor audit, supplier audit, external audit, or regulatory inspection involving computerized systems or IT controls; Strong technical writing, client communication, and organizational skills, with the ability to manage several concurrent assignments; US work authorization and residence in the United States

Nice to have

Consulting or managed-services experience supporting multiple life sciences clients; IT infrastructure qualification experience involving cloud platforms, servers, networks, or backup and recovery; Experience with Microsoft 365, SharePoint, Azure, Veeva, MasterControl, or comparable regulated platforms; Direct participation in an FDA or other health-authority inspection; Familiarity with SOX IT general controls or SOC 2 readiness; Experience estimating engagements, mentoring colleagues, or leading validation programs; Relevant quality, validation, or IT audit credentials