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.





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

Strong validation experience across clinical and quality systems, including:

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

Business Analysis skills

Process mapping and data flow analysis

General pharmaceutical, biotechnology or CRO environments

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📌 Validation Manager (Madrid)
🏢 Planet Pharma
📍 Madrid