Senior GxP IT Validation Lead for Regulated Systems

van den Boom & Associates; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

van den Boom & Associates is seeking an experienced GxP IT validation professional in the United States. You will lead validation engagements for SaaS and cloud systems, write and execute risk-based validation plans, and collaborate with client QA and IT teams to establish intended use and traceability.

You will maintain validated state, assess changes, support audits, and drive practical, defensible validation records. Strong technical writing and US residency are required.

Qualifications

• Substantial hands-on experience in GxP computerized system validation or IT quality within life sciences.
• Authoring validation deliverables, coordinating testing, and resolving QA comments.
• Practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles including ALCOA+.
• Experience validating regulated SaaS, cloud-hosted applications, or other computerized systems, with understanding of supporting IT infrastructure.
• Ability to distinguish GxP impact, intended use, and system risk, and translate judgments into a validated approach.
• Experience maintaining validated systems through change control, release assessments, or periodic reviews.
• Experience supporting QA reviews, sponsor audits, supplier audits, or regulatory inspections.
• US work authorization and residence in the United States.

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 computer software assurance principles, using supplier documentation and testing where justified.
• Assess SaaS and cloud systems used in regulated work (eQMS, eSignature, LIMS, eTMF, document management).
• Assess Microsoft 365 or SharePoint configurations for GxP records/workflows.
• Plan and document qualification of supporting IT infrastructure with technical specialists.
• Explain validation decisions and resolve review comments with client QA.

Skills

GxP validation

21 CFR 11

EU Annex 11

GAMP 5

Data integrity ALCOA+

SaaS validation

Change control

QA coordination

US work authorization

Tools

Microsoft 365

SharePoint

Azure

Veeva

MasterControl

Job description

van den Boom & Associates is seeking an experienced GxP IT validation professional in the United States. You will lead validation engagements for SaaS and cloud systems, write and execute risk-based validation plans, and collaborate with client QA and IT teams to establish intended use and traceability.

You will maintain validated state, assess changes, support audits, and drive practical, defensible validation records. Strong technical writing and US residency are required.