Validation Lead - CSV/GXP

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

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

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