GxP IT Validation Lead

van den Boom & Associates

About The Position

The GxP IT Validation Lead is a hands-on role in an IT Services practice providing managed IT, cybersecurity, and regulated-industry compliance services to life sciences and biotech companies. The role leads validation engagements and helps clients maintain computerized systems in a validated, inspection-ready state. The lead scopes, authors, executes, and documents risk-based validation work for SaaS and cloud applications, computerized systems, and supporting IT infrastructure, working with client Quality Assurance (QA), system owners, and the IT delivery team to define intended use, assess risk, and produce defensible records. Client QA retains approval authority for validation deliverables and GxP change decisions; the role leads execution, recommends appropriate scope, and explains technical rationale. Responsibilities also include maintaining validation status and ongoing GxP compliance, assessing changes and supplier releases, supporting audits and inspections, improving validation methods and templates, coordinating work with technical and compliance specialists, and providing technical guidance and training. The role may support SOX ITGC or SOC 2 engagements within demonstrated competence, but these are secondary to GxP validation. Practice leadership retains responsibility for commercial pricing, sales commitments, staffing decisions, and ownership of the service portfolio. The position offers a potential path toward broader technical and practice leadership as the service grows.

Requirements

Substantial hands-on experience in GxP computerized system validation or IT quality within life sciences; typically seven or more years of relevant experience, with demonstrated delivery capability carrying more weight than a specific tenure threshold.
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 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 Haves

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.

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 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, including eQMS, eSignature, LIMS, eTMF, and document management platforms.
Assess Microsoft 365 or SharePoint configurations when intended for GxP records or workflows.
Plan and document qualification of supporting IT infrastructure, including relevant server, network, cloud, backup, and disaster recovery capabilities, with technical specialists.
Explain validation decisions and resolve review comments with client QA.
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.
Prepare validation records and IT control evidence for client QA reviews, sponsor audits, supplier audits, and regulatory inspections.
Explain completed work 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.
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 the role's area of expertise.
Help train IT staff on GxP procedures relevant to their assigned work.
Track delivery effort and identify opportunities to improve quality and efficiency.
Support SOX ITGC or SOC 2 engagements within demonstrated competence, with specialist involvement coordinated by practice leadership.