GxP Computerised Systems Validation Consultant

Intelance; Greater London; Remote; GBP 101,000 - 129,000; Full time

Job summary

Intelance, a UK-based technology, AI and cyber assurance firm, is seeking a freelance due diligence reviewer to assess GxP validated software used in drug development. You will work remotely in the UK, with occasional London meetings, delivering findings for client reports.

The role requires deep experience in computerised system validation, GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and CDISC standards, with the ability to produce clear, actionable fixes for potential deal-impacting issues.

Qualifications

• At least five years of computerised system validation in a GxP setting.
• Hands-on use of GAMP 5, 21 CFR Part 11 and EU GMP Annex 11.
• Experience validating or auditing systems that produce clinical trial or regulatory submission outputs.
• Working knowledge of CDISC data standards.
• Clear, plain writing that founders, buyers and lawyers can follow.
• Experience validating systems that use machine learning or AI is a strong plus.

Responsibilities

• Review the validation approach, records and evidence for platforms that produce clinical trial and real world evidence outputs.
• Check audit trails, access controls, electronic records and change control against 21 CFR Part 11 and EU GMP Annex 11.
• Judge whether the validation is proportionate to risk, using GAMP 5 and Computer Software Assurance thinking.
• Check how validation is kept current when AI workflows and machine learning models change.
• Check that outputs follow the expected data standards, such as CDISC SDTM and ADaM.
• Rate each finding by how it could affect the deal, and write clear, practical fixes.

Skills

GxP validation

GAMP 5

21 CFR Part 11

EU GMP Annex 11

CDISC data standards

AI/ML experience

Clear writing

Job description

About Intelance

Intelance is an independent technology, AI and cyber assurance firm based in the UK. We help organisations check, govern and improve their technology through enterprise architecture, AI governance, cyber assurance and data governance work. We are building a small panel of senior associates to deliver technology and AI due diligence on company sales and investments.

The role

You will check whether software used in drug development is validated to GxP standards, as part of technology due diligence for clients who are selling, buying or investing in life sciences technology companies. Pharmaceutical buyers want proof that a platform producing trial and regulatory outputs works reliably, keeps a full audit trail and would stand up to an inspection.

You report to an Intelance engagement partner and work alongside our pharma specialist and technology due diligence lead, who bring your findings into the final report.

What you will do

• Review the validation approach, records and evidence for platforms that produce clinical trial and real world evidence outputs.

• Check audit trails, access controls, electronic records and change control against 21 CFR Part 11 and EU GMP Annex 11.

• Judge whether the validation is proportionate to risk, using GAMP 5 and Computer Software Assurance thinking.

• Check how validation is kept current when AI workflows and machine learning models change.

• Check that outputs follow the expected data standards, such as CDISC SDTM and ADaM.

• Rate each finding by how it could affect the deal, and write clear, practical fixes.

What you will bring

• At least five years of computerised system validation in a GxP setting.

• Hands on use of GAMP 5, 21 CFR Part 11 and EU GMP Annex 11.

• Experience validating or auditing systems that produce clinical trial or regulatory submission outputs.

• Working knowledge of CDISC data standards.

• Clear, plain writing that founders, buyers and lawyers can follow.

• Experience validating systems that use machine learning or AI is a strong plus.

How the work is set up

• Remote within the UK, with occasional meetings in London.

• Around 3 to 5 days between late November 2026 and the end of January 2027, with further engagements as the practice grows.

• Freelance, or through your own limited company, at £550 to £700 a day depending on experience. Reasonable travel costs for client meetings are covered.

• A panel agreement, NDA and statement of work are signed before any client details are shared.

• You work from an Intelance mailbox and use our evidence log and report templates, so every report meets the same standard.