07 nov
|
Straumann Group
|
Granada
07 nov
Straumann Group
Granada
Experteer Overview
In this role you will lead computerized systems validation (CSV) and test management for Straumann’s Integral Business Applications, delivering validated enterprise solutions such as SAP and Salesforce. You’ll drive global CSV capabilities, align QA and compliance with IT, and support major initiatives like S/4HANA. This position sits at the intersection of IT, QA, and business processes to enable compliant, high-quality deployments. You will enable transformation through strong leadership and cross-functional collaboration.
Compensaciones / Beneficios
• Manage validation documentation across SDLC with stakeholders (validation strategy, test plans, requirements, specs, SOPs, validation records)
• Provide CSV guidance to implementation and update projects
• Improve CSV standards in line with regulatory changes and IT/QA alignment
• Define and drive Test Management for Business Applications and major initiatives (e.g., S/4HANA)
• Collaborate with QA, Test Management, and Compliance to align deliverables with CSV guidelines
• Coordinate local CSV/QA representatives to meet global CSV compliance requirements
• Provide training and coaching on CSV standards and test approaches
• Work with IT SAP and other business application stakeholders to ensure regulatory compliance and project quality
• Participate in internal and external audits when needed
• Engage in cross-functional collaboration to support ALM strategy and lifecycle management
Responsabilidades
• 10+ years of experience in CSV, QM, Test and Project Management with leadership experience
• Strong expertise in GxP requirements and 21 CFR Part 11, GAMP5, Annex11
• Proven ability to apply CSV and documentation best practices in regulated industries
• Strong project and test management skills with ability to adapt to compliance deliverables
• Familiarity with multiple software development methodologies and CSV adaptation
• Excellent communication and stakeholder management, with ability to build cross-organizational relationships
• Resilience and adaptability to handle challenges
• Fluent English (written and spoken); additional languages considered an asset (German)
Requisitos principales
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📌 Global Business Applications CSV and Test Management Lead (Granada)
🏢 Straumann Group
📍 Granada