Global CSV & Test Management Lead — Enterprise Apps (Hybrid)

Straumann Group; Ourense; Híbrido; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Straumann Group in Spain is seeking an experienced CSV and Test Management Lead to drive the delivery of validated software solutions such as SAP, Salesforce and other enterprise applications within the Global Business Applications department.

The role requires 10+ years in CSV, QM and project management with leadership, strong knowledge of 21 CFR Part 11, GAMP 5 and Annex 11, and proven ability to coordinate with IT, QA and compliance teams across functions and regions.

Formación

• 10+ years in CSV, QM, and test/project management with leadership.
• Deep knowledge of 21 CFR Part 11, GAMP 5, Annex 11.
• Experience establishing CSV processes in regulated environments.
• Strong communication and stakeholder management skills.

Responsabilidades

• Lead validation documentation and traceability activities for SDLC.
• Provide CSV guidance to project teams.
• Improve CSV standards and regulatory alignment with IT/QA.
• Define and drive Test Management for SAP and S/4HANA initiatives.
• Coordinate with QA, Compliance, and IT stakeholders.
• Train stakeholders on CSV standards.
• Collaborate with SAP and other business applications.
• Support internal and external audits.

Conocimientos

CSV Leadership

Test Management

GxP Regulations

Regulatory Compliance

SAP / S/4HANA

Stakeholder Management

English Fluency

Educación

Bachelor's or Master's in Computer Science or related field

Herramientas

SAP

Salesforce

ALM Tools

Descripción del empleo

Straumann Group in Spain is seeking an experienced CSV and Test Management Lead to drive the delivery of validated software solutions such as SAP, Salesforce and other enterprise applications within the Global Business Applications department.

The role requires 10+ years in CSV, QM and project management with leadership, strong knowledge of 21 CFR Part 11, GAMP 5 and Annex 11, and proven ability to coordinate with IT, QA and compliance teams across functions and regions.