vandenboomassociates - GxP IT Validation Lead

• Lead validation engagements • 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 appropriate to each system and its intended use. • Apply risk-based CSV and applicable computer software assurance principles, using supplier documentation and testing where justified. • 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 when clients intend to use them for GxP records or workflows. • Plan and document qualification of supporting IT infrastructure, including relevant server, network, cloud, backup, and disaster recovery capabilities, in collaboration with technical specialists. • Explain validation decisions and resolve review comments with client QA. • Maintain the validated state • Maintain system inventories, validation status records, and scheduled review activities for assigned clients. • Assess changes, vendor releases, and system updates for GxP impact and recommend proportionate testing and documentation. • Perform or coordinate periodic reviews, supplier assessments, and audit trail reviews within the agreed scope and client-approved procedures. • Assess electronic record and signature controls, access management, audit trails, retention, and data integrity against applicable requirements and intended use. • Identify gaps, document risks, and track agreed remediation actions with accountable owners. • Support audits and inspections • Prepare validation records and IT control evidence for client QA reviews, sponsor audits, supplier audits, and regulatory inspections. • Explain work you have performed and the rationale supporting validation scope and testing decisions. • Support responses to observations and follow remediation actions through closure. • Escalate compliance concerns, delivery constraints, and unresolved risks promptly. • Improve delivery • Maintain practical SOPs, templates, and validation methods that support consistent, risk-based delivery. • 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 the GxP procedures relevant to their assigned work. • Track delivery effort and identify opportunities to improve quality and efficiency. • 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. • 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. • SUCCESS IN THE FIRST YEAR • Assigned clients have a documented system inventory, clear validation status, and agreed priorities for any gaps. • Validation work is completed to an agreed scope and schedule, with clear documentation accepted through client QA review. • Periodic reviews, change assessments, and other assigned recurring activities are completed on schedule, with exceptions documented and escalated. • Audit and inspection requests receive timely, accurate evidence and clear explanations. • Identified risks and findings have accountable owners, agreed actions, and tracked follow-through. • Reusable templates and delivery methods improve consistency without adding unnecessary documentation. • Delivery effort is recorded accurately so leadership can plan capacity and price work appropriately. • Client QA approves validation deliverables and GxP change decisions. We execute and recommend. • Client information remains confidential and separate from other clients' records. • Work is assigned according to demonstrated competence, with specialist support and escalation when needed. • We favor clear, proportionate controls and defensible evidence that fit each client's regulated activities.