We are partnering with a general 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
- Global pharmaceutical, biotechnology or CRO environments

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