Navikenz
Validation Lead - CSV/GXP
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Summary of the role:
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
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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
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Behavioral Expectations
- Proactive in identifying risks and compliance gaps during client-facing sessions
- Ability to prioritize and escalate 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
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