GxP IT Validation
Posted 15 Oct 2026
Advertised as “GxP IT Validation Lead”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 7+ yrs
- Management level
- People management
- Employment
- Remote
- Contract
- Full-time
No salary listed for this role.
About the Role
Our IT Services practice provides managed IT, cybersecurity, and regulated-industry compliance services to life sciences and biotech companies, from seed stage through public companies. We help clients implement technology, operate it reliably, and demonstrate that the controls supporting regulated work are effective.
The Opportunity
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We are looking for an experienced, hands-on GxP IT validation professional who can lead validation engagements and help clients keep computerized systems in a validated, inspection-ready state.
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You will personally scope, write, execute, and document risk-based validation work for SaaS and cloud applications, computerized systems, and supporting IT infrastructure. You will work closely with client Quality Assurance (QA), system owners, and our IT delivery team to establish intended use, assess risk, and produce clear, defensible validation records.
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Client QA retains approval authority for validation deliverables and GxP change decisions. You lead execution, recommend the appropriate scope, and explain the technical rationale.
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This role offers a path toward broader technical and practice leadership as the service grows. The initial priority is excellent validation delivery and ongoing GxP IT compliance. Prior experience building a consulting practice or managing a department is welcome but is not required.
Key Responsibilities
Lead validation engagements
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Define intended use, system boundaries, GxP impact, and risk-based validation scope with client QA and system owners.
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Prepare and execute validation plans, requirements, risk assessments, test protocols, traceability records, and summary reports appropriate to each system and its intended use.
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Apply risk-based CSV and applicable computer software assurance principles, using supplier documentation and testing where justified.
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Assess SaaS and cloud systems used in regulated work, such as eQMS, eSignature, LIMS, eTMF, and document management platforms.
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Assess Microsoft 365 or SharePoint configurations when clients intend to use them for GxP records or workflows.
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Plan and document qualification of supporting IT infrastructure, including relevant server, network, cloud, backup, and disaster recovery capabilities, in collaboration with technical specialists.
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Explain validation decisions and resolve review comments with client QA.