Remote GxP Validation Consultant Life Sciences Due Diligence

Intelance; United States; Remote; USD 136,000 - 173,000; Full time

Benefits offered by this job

Remote work

Panel NDA & SoW signed

Travel costs covered

Job summary

Intelance is seeking a freelance technology due diligence specialist to validate GxP systems used in drug development for buyers and investors. You will assess validation evidence, audits, access controls and data standards, and craft practical fixes for identified gaps.

The role focuses on AI/ML workflows and regulatory data outputs and spans remote work with occasional London meetings. Reporting to an engagement partner, you will collaborate with pharma specialists and the due diligence lead

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

CDISC data standards

Regulatory submissions outputs

AI/ML validation

Plain writing

Job description

Intelance is seeking a freelance technology due diligence specialist to validate GxP systems used in drug development for buyers and investors. You will assess validation evidence, audits, access controls and data standards, and craft practical fixes for identified gaps.

The role focuses on AI/ML workflows and regulatory data outputs and spans remote work with occasional London meetings. Reporting to an engagement partner, you will collaborate with pharma specialists and the due diligence lead