Experteer Overview
In this role, you lead computer systems validation and test management for Straumann’s Global Business Applications. You partner with QA, Compliance, and IT teams to ensure compliant delivery of enterprise apps like SAP and S/4HANA during digital transformation. You drive standardized CSV practices, oversight of validation documentation, and global compliance alignment. You will shape test strategies, coach stakeholders, and navigate audits to enable reliable, compliant business solutions. This is a pivotal role that ties regulatory excellence to strategic modernization across the organization.

Compensaciones / Ventajas
• Manage and review validation documentation across SDLC with stakeholders (validation strategy, test plans, requirements, specs, SOPs, qualification docs)
• Provide CSV guidance to implementation or update project teams
• Improve CSV standards and processes in line with IT and QA and regulatory changes
• Define and drive test management for business applications and initiatives like S/4HANA
• Coordinate with Quality Assurance,



Test Management and Compliance to align deliverables with CSV guidelines
• Coordinate local CSV and QA representatives to meet global CSV compliance requirements
• Provide training and coaching on CSV standards and test approaches
• Collaborate with SAP and other business application stakeholders to ensure compliance and project quality
• Participate in internal and external audits when needed

Responsabilidades
• 10+ years experience in CSV, QM, test and project management
• 2+ years in a leadership role
• Strong expertise in GxP and 21 CFR Part 11, GAMP 5 and Annex11
• Experience with regulated industries and CSV documentation best practices
• Strong project and test management skills and ability to adapt to various methodologies
• Excellent communication and stakeholder management skills
• Fluent English (spoken and written); German is a plus

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