Senior CSV/GxP Validation Lead – AI in Pharma

Navikenz; Greater London; On-site; GBP 120,000 - 160,000; Full time

Job summary

Navikenz is seeking a Validation Lead in London to partner with pharma clients, ensuring CSV and GxP compliance for AI and GenAI systems. The role is client‑facing, focused on closing validation requirements, resolving compliance gaps, and providing assurance that regulatory expectations are fully met.

You will lead on-site validation engagements, collaborate with client SMEs and regulators, and deliver robust documentation for regulatory submissions and audits while managing timelines and

Qualifications

• 15+ years of IT experience in pharma/life sciences
• Deep expertise in CSV and GxP compliance with regulatory focus
• Proven track record delivering validation programs for AI/GenAI systems in regulated settings

Responsibilities

• Lead on-site validation engagements and close requirements with client stakeholders
• Partner with client teams to align validation deliverables with regulatory expectations
• Facilitate workshops, walkthroughs and discussions to confirm compliance and readiness
• Provide clear documentation and evidence to support regulatory submissions and audits

Skills

CSV/GxP compliance

Regulatory focus

AI/GenAI validation

Job description

Navikenz is seeking a Validation Lead in London to partner with pharma clients, ensuring CSV and GxP compliance for AI and GenAI systems. The role is client‑facing, focused on closing validation requirements, resolving compliance gaps, and providing assurance that regulatory expectations are fully met.

You will lead on-site validation engagements, collaborate with client SMEs and regulators, and deliver robust documentation for regulatory submissions and audits while managing timelines and