27 oct
|
Planet Pharma
|
España
27 oct
Planet Pharma
España
We are partnering with a integral 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
📌 Validation Manager (España)
🏢 Planet Pharma
📍 España