Senior GxP IT Validation Lead for Regulated SaaS

van den Boom & Associates LLC; United States; On-site; USD 130,000 - 170,000; Full time

Job summary

van den Boom & Associates LLC is seeking a hands-on GxP IT validation professional to lead validation engagements for life sciences clients in the United States. You will scope, write, execute, and document risk-based validation work for SaaS, cloud applications, and supporting IT infrastructure, collaborating with client QA and system owners to ensure validated, inspection-ready records.

You will maintain validated state, assess changes and vendor releases, support audits, and help improve

Qualifications

• Substantial hands-on experience in GxP computerized system validation or IT quality within life sciences.
• Authoring deliverables, executing tests, resolving QA comments, and completing validated packages.
• Strong writing and communication skills for client-facing work.
• Experience with regulated SaaS/cloud apps and IT infrastructure supporting validated systems.
• Understanding GxP impact, intended use, and risk-based validation approaches.

Responsibilities

• Lead validation engagements: define intended use, scope, risk, and validation plans.
• Prepare and execute validation plans, requirements, risk assessments, test protocols, and traceability records.
• Apply CSV and computer software assurance principles with supplier documentation.
• Assess SaaS/cloud systems and Microsoft 365/SharePoint for GxP records/workflows.
• Document qualification of IT infrastructure in collaboration with technical specialists.
• Explain validation decisions and resolve QA comments with client QA.

Skills

GxP validation

IT quality

Technical writing

Client communication

Risk assessment

Tools

Microsoft 365

SharePoint

Veeva

MasterControl

Job description

van den Boom & Associates LLC is seeking a hands-on GxP IT validation professional to lead validation engagements for life sciences clients in the United States. You will scope, write, execute, and document risk-based validation work for SaaS, cloud applications, and supporting IT infrastructure, collaborating with client QA and system owners to ensure validated, inspection-ready records.

You will maintain validated state, assess changes and vendor releases, support audits, and help improve