Validation Lead - CSV/GXP

Navikenz; Greater London; On-site; GBP 120,000 - 170,000; Full time

Job summary

Navikenz seeks a Validation Lead to partner with pharma clients in London, ensuring CSV and GxP compliance for emerging AI and GenAI systems. This client-facing role focuses on closing validation requirements, addressing compliance gaps, and delivering regulatory-ready evidence.

With a background of 15+ years in IT within pharma, you will lead on-site engagements and collaborate with client SMEs and regulators to ensure readiness and regulatory submissions and audits.

Qualifications

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

Responsibilities

• Lead on-site validation engagements, ensuring closure of 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.
• Act as the primary validation contact for the client, ensuring transparency and confidence in delivery.

Skills

CSV compliance

GxP compliance

Regulatory interpretation

AI/GenAI validation

Client-facing communication

Job description

As a Validation Lead you will partner directly with pharma clients in London, ensuring CSV and GxP compliance for emerging AI and GenAI systems. This role is client-facing, focused on closing validation requirements, resolving compliance gaps, and providing assurance that regulatory expectations are fully met.

Experience & Background

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

Core Expertise

• End-to-end validation strategy and execution for GxP systems
• Regulatory interpretation and application to emerging AI/GenAI technologies
• Technical grounding to engage confidently with client SMEs and regulators

Client-Facing Responsibilities

• Lead on-site validation engagements, ensuring closure of 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

Engagement & Communication

• Act as the primary validation contact for the client, ensuring transparency and confidence in delivery
• Anticipate regulatory concerns and proactively address them during client interactions
• Present validation outcomes with authority, handling challenges and clarifications professionally
• Proactive in identifying risks and compliance gaps during client-facing sessions
• Ability to prioritize and elevate issues to client leadership when required
• Maintain composure and professionalism under pressure, especially in regulatory closure discussions
• Flexibility to support extended/odd hours during critical validation milestones