Senior GxP IT Validation Lead

van den Boom & Associates; Oregon; Hybrid; USD 120,000 - 170,000; Full time

Job summary

van den Boom & Associates is seeking an experienced GxP IT validation professional to lead validation engagements for regulated life sciences clients in the United States. You will scope, write, execute, and document risk-based validation for SaaS and cloud solutions, collaborate with client QA, and ensure inspection-ready records.

The role offers growth toward practice leadership and exposure to SOX ITGC or SOC 2 as needed.

Qualifications

• 7+ years in GxP computerized system validation or IT quality.
• Own validation engagements, authoring deliverables and coordinating testing.
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity ALCOA+.
• Experience validating regulated SaaS, cloud-hosted applications, or other computerized systems.
• Translate risk judgments into justified validation approaches.
• Experience with change control, release assessments, and periodic reviews.
• Experience supporting QA reviews, sponsor audits, supplier audits, or inspections.
• Strong writing, client communication and multi-project management.
• US work authorization and residence in the United States.

Responsibilities

• Lead validation engagements with clients, define scope and risk.
• Prepare and execute validation plans, requirements, tests, and reports.
• Maintain validated state, inventories, and scheduled reviews.
• Assess system changes and vendor updates for GxP impact.
• Support audits and inspections with validation records and evidence.
• Improve delivery with SOPs, templates, and repeatable methods.
• Coordinate with IT engineers, compliance staff, and consultants.
• Train IT staff on GxP procedures relevant to assignments.

Skills

GxP validation

Regulated SaaS validation

Technical writing

Client communication

Risk-based validation

Tools

Microsoft 365

SharePoint

Azure

Veeva

MasterControl

Job description

van den Boom & Associates is seeking an experienced GxP IT validation professional to lead validation engagements for regulated life sciences clients in the United States. You will scope, write, execute, and document risk-based validation for SaaS and cloud solutions, collaborate with client QA, and ensure inspection-ready records.

The role offers growth toward practice leadership and exposure to SOX ITGC or SOC 2 as needed.