CSV Lead

About the Role

This is the hands-on core of the validation function. You will build and run the validation framework for AOTM Life products writing the documents, executing the assessments, training the teams, and standing in front of customer auditors to explain all of it. You are the person who turns a compliance strategy into artefacts that survive contact with a pharma auditor.

Key Responsibilities:

Build the Validation Framework

• Conduct baseline CSV and GxP gap assessments across software, cloud and AI/ML components
• Author and maintain core CSV documentation: CSV Policy, system inventory and GxP impact assessment, Validation Master Plan, URS, risk assessment procedures and validation summary reports
• Define intended use statements and GAMP 5 categorisation for each product and component
• Maintain traceability through the RTM: URS specifications risk assessment IQ/OQ/PQ release evidence
• Build reusable validation packages, each new customer implementation starts from a qualified baseline

Execute the Lifecycle

• Author, execute and peer-review test protocols and scripts (IQ/OQ/PQ), pre- and post-execution
• Perform periodic review: audit trail and access review, incident and change history, backup and restore, patch management, disaster recovery and revalidation decisions
• Assess GxP impact of change and incident records; gate releases on validated-state impact
• Manage deviations and CAPA end to end investigation, root cause analysis, corrective action and effectiveness check

Audits, Customers & Training

• Complete and defend customer CSV questionnaires and supplier assessments
• Prepare for, host and support pharma customer audits; drive remediation to closure
• Run mock audits and inspection-readiness drills; coach engineering, DevOps and delivery teams on how to be audited
• Deliver GxP, data integrity and CSV awareness training; own the training matrix and records

Security & AI Validation

• Contribute to the ISO/IEC 27001:2022 internal audit programme as a certified Lead Auditor Ninestars | CSV Lead GxP Validation | 1
• Assess and document Part 11 technical controls: access management, audit trails, electronic signatures, retention and time stamps
• Apply validation controls to AI and agentic components human-in-the-loop checkpoints, model change control and output verification

Mandatory Skills & Experience:

• 8-12 years in Computer System Validation, GxP compliance, IT QA or IT audit within life sciences
• Hands-on authorship of VMP, URS, risk assessments, IQ/OQ/PQ and RTM written, not only reviewed
• Strong working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and ALCOA+ data integrity
• Practical experience with periodic review, change control, deviation and CAPA management in a regulated environment
• Direct participation in pharma supplier audits, on either side of the table
• ISO/IEC 27001:2022 Lead Auditor certified, or able to certify within three months of joining
• Hands-on with at least one validated enterprise platform Veeva Vault, LIMS, eLN, DMS, SAP or equivalent
• Excellent technical writing: clear, traceable, defensible documentation

Desirable Skills & Experience

• SaaS, cloud platform or enterprise software validation
• AI/ML systems from a validation or governance perspective; exposure to NIST AI RMF or ISO/IEC 42001
• CSA (Computer Software Assurance) applied in practice
• Test management tooling: qTest, HP ALM, IBM RQM, Jira or Azure DevOps
• ITIL Foundation or practical ITSM experience (ServiceNow or equivalent)
• Certified investigator or certified trainer status for RCA, CAPA, GxP or data integrity
• Exposure to ISO 9001, GDPR or HIPAA
• Agile / DevOps release models in a validated environment

Certifications:

Mandatory:

• ISO/IEC 27001:2022 Lead Auditor
• CSV or GAMP 5 credential

Desirable:

• NIST AI RMF Foundation
• ITIL Foundation
• ASQ CQA

Why Join Us

• Zero-to-one. Design the frameworks, documentation and audit readiness from scratch

• Front-row visibility. Partner with the CTAO and CBO during first pharma engagements

• Future-proof skill set. Work at the intersection of AI, cloud and life sciences compliance

• Accelerated growth. Clear runway into the CSV Head and senior GRC track