Overview In this role you lead CSV and Test Management for Straumann's Global Business Applications, driving validated ERP and enterprise solutions like SAP and Salesforce. You will shape CSV standards, oversee lifecycle documentation, and support global compliance through training and audits. You will collaborate with IT, QA, and business stakeholders during a digital transformation and major initiatives such as S/4HANA.

This is a hands-on leadership position with cross-functional impact and regulatory accountability.

Responsabilidades Manage validation documentation across SDLC with stakeholders (validation strategy, test plans, user requirements, functional/configuration specs, SOPs, test records)

Provide CSV guidance to implementation or update project teams

Continuously improve CSV standards to align with IT and QA and regulatory changes

Define, drive and implement Test Management for Business Applications and initiatives like S/4HANA

Coordinate with QA, Compliance, and Test teams to align deliverables with CSV guidelines

Coordinate local CSV and QA representatives to meet general CSV compliance requirements





Provide training and coaching on CSV standards and testing approaches

Collaborate with SAP and other Business Application stakeholders to ensure compliance and project quality

Participate in internal and external audits as needed

Requisitos principales 10+ years in CSV, QM, Test and Project Management with at least 2 years in a leadership role

Strong expertise in GxP, 21 CFR Part 11, GAMP 5 and Annex11

Experience establishing CSV/documentation best practices in regulated environments

Strong project and test management skills with ability to deliver compliance-focused outputs

Familiarity with multiple software development methodologies and adapting them for CSV

Excellent communication and stakeholder management skills

Resilience and adaptability to challenges

Fluent English; additional language (German) is an asset strong communication stakeholder management leadership

CSV (Computerized Systems Validation)

GxP compliance

21 CFR Part 11

📌 Global Business Applications CSV and Test Management Lead (Sevilla)
🏢 Straumann Group
📍 Sevilla