Experteer Overview
In this role you lead computerized systems validation (CSV) and test management for Straumann’s Global Business Applications. You drive compliance, QA collaboration, and validation across SAP, Salesforce, and other enterprise apps during a digital transformation. You’ll influence validation standards, guide project teams, and support major initiatives like S/4HANA to ensure quality and regulatory alignment. This is a cross-functional, impact-oriented position with a strong focus on governance, risk, and scalable processes.

Compensaciones / Beneficios
• Manage validation documentation across SDLC with stakeholders (validation strategy, test plans, requirements, specs, SOPs, test records)
• Provide CSV guidance to implementation and update projects
• Improve CSV standards aligning with IT and QA and regulatory changes
• Define, drive, and implement Test Management for Business Applications and initiatives like S/4HANA
• Collaborate with QA, Test Management, and Compliance to align deliverables with CSV guidelines




• Coordinate local CSV/QA representatives to meet integral CSV compliance
• Provide training and coaching on CSV standards and testing approaches
• Engage with SAP and other business application stakeholders to ensure compliance and project quality
• Participate in internal/external audits when required

Responsabilidades
• Bachelor in Computer Science
• 10+ years in CSV, QM, Test and Project Management
• 2+ years in a leadership role
• Strong GxP knowledge and familiarity with 21 CFR Part 11, GAMP 5, Annex 11
• Experience adapting CSV and documentation best practices in regulated industries
• Strong project and test management capabilities with solution-oriented compliance deliverables
• Familiar with multiple software development methodologies and adapting them for CSV
• Strong communication and stakeholder management, with cross-organizational relationship building
• Fluent English; German is an asset

Requisitos principales
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📌 Global Business Applications CSV and Test Management Lead (Bilbao)
🏢 Straumann Group
📍 Bilbao