Validation Manager

Contract Validation Manager (Clinical Systems / CSV) 📍 Location: Europe (Remote/Hybrid Flexibility) Initial 6-Month Contract (Extension Possible) 🚀 Start Date: ASAP

We are partnering with a global Life Sciences organisation undergoing a number of critical digital and compliance initiatives and are seeking an experienced Validation Manager to lead validation activities across regulated clinical and quality systems.

This is an excellent opportunity for a hands-on CSV professional who combines strong validation expertise with leadership capabilities and experience operating within highly regulated GxP environments.

Key Responsibilities

• Lead validation activities for regulated GxP systems throughout the SDLC.
• Author and review validation deliverables including URS, risk assessments, test scripts, test execution evidence, validation reports and traceability documentation.
• Collaborate with business, quality, IT and vendor stakeholders to ensure compliant system implementation and operation.
• Provide guidance on Computer Systems Validation (CSV), data integrity and regulatory compliance requirements.
• Support validation activities across clinical, quality and enterprise platforms.

Essential Experience

5+ years' experience in Computer Systems Validation within Life Sciences

Strong validation experience across clinical and quality systems, including:

• Veeva QDocs
• Veeva QMS
• Clinical Systems (CTMS, EDC, IRT advantageous)

Experience validating or implementing Learning Management Systems (LMS), ideally:

• SumTotal
• Cornerstone
• SuccessFactors LMS
• Similar regulated LMS platforms

Experience with Identity & Access Management systems, including:

• OKTA
• Identity Service Cloud
• SSO / Access Management platforms

Strong understanding of:

• GAMP 5
• Annex 11
• 21 CFR Part 11
• Data Integrity principles

Hands-on experience creating and reviewing:

• URS
• Functional Requirements
• Test Scripts
• Validation Documentation
• Test Reports

Previous leadership, team lead or line management experience

Desirable Experience

• Business Analysis skills
• Process mapping and data flow analysis
• Agile project environments
• Global pharmaceutical, biotechnology or CRO environments