08 nov
|
Straumann Group
|
Jaén
08 nov
Straumann Group
Jaén
Experteer Overview In this role, you lead computerized systems validation (CSV) and test management for Straumann's Global Business Applications. You will drive compliance, quality, and validation activities across enterprise applications like SAP and Salesforce, supporting the digital transformation and growth agenda. You partner with QA, Compliance, and IT teams to ensure compliant delivery of validated solutions. You will shape CSV standards, guidance, and training, enabling integral consistency and continuous improvement. This is a strategic, cross-functional leadership role with impact on mission-critical business systems.Compensaciones / Beneficios
- Oversee and review validation documents across SDLC with stakeholders (Validation Strategy, Test Plans, URs, FS, SOPs, Qualification Records).
- Provide CSV guidance to implementation and update projects.
- Drive continuous improvement of CSV standards aligned with IT and QA and regulatory changes.
- Define, drive, and implement Test Management for Business Applications and initiatives like S/4HANA within the ALM framework.
- Collaborate with QA, Test Management, and Compliance to align deliverables to CSV guidelines.
- Coordinate local CSV/QA representatives to meet global CSV compliance requirements.
- Provide training and coaching on CSV standards and testing approaches.
- Work with IT SAP and other business stakeholders to ensure compliance and project quality.
- Participate in internal and external audits when needed.Responsabilidades
- 10+ years in CSV, QM, Test and Project Management, with leadership experience (2+ years).
- Strong knowledge of GxP and 21 CFR Part 11, GAMP5, Annex11 requirements.
- Experience applying GxP regulations, CSV, and documentation best practices in regulated settings.
- Proven project and test management skills with a focus on compliant deliverables.
- Familiarity with multiple software development methodologies and adapting them for CSV.
- Excellent communication and stakeholder management across functions and external partners.
- Resilience to adapt to challenges and drive solutions.
- Fluent English; additional languages (e.G., German) are a plus.Requisitos principales
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📌 Global Business Applications Csv And Test Management Lead (Jaén)
🏢 Straumann Group
📍 Jaén