08 nov
|
Straumann Group
|
Soria
08 nov
Straumann Group
Soria
Experteer Overview
In this role you lead the Computer Systems Validation (CSV) and test management for Straumann’s Global Business Applications. You will shape CSV standards, drive validation across SAP, Salesforce and other enterprise apps, and support global compliance initiatives. You collaborate with QA, IT and business stakeholders to ensure compliant, high-quality delivery within a digital transformation program. You’ll work on major initiatives like S/4HANA, delivering validated systems that enable growth and innovation. This is a chance to impact how enterprise applications support the company’s mission to be customer-focused and innovative.
Compensaciones / Beneficios
• Manage validation documentation across SDLC in collaboration with stakeholders
• Provide CSV guidance to project teams on validation activities
• Drive continuous improvement of CSV standards in line with regulatory changes
• Define, drive and implement Test Management for Business Applications and initiatives like S/4HANA
• Partner with QA,
Test Management and Compliance to align deliverables with CSV guidelines
• Coordinate local CSV and QA representatives to meet general compliance requirements
• Provide training and coaching on CSV standards and testing approaches
• Collaborate with IT SAP and other stakeholders to ensure compliance and project quality
• Participate in internal and external audits as needed
Responsabilidades
• 10+ years in CSV, QM, Test and Project Management
• At least 2 years in a leadership role
• Strong expertise in GxP and 21 CFR Part 11, GAMP 5, Annex 11
• Experience adapting CSV and documentation best practices for regulated industries
• Strong project and test management skills with focus on compliance deliverables
• Familiarity with multiple software development methodologies and adapting them for CSV
• Excellent communication and stakeholder management abilities
• Fluent English; German is a plus
Requisitos principales
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📌 Global Business Applications CSV and Test Management Lead (Soria)
🏢 Straumann Group
📍 Soria