Global CSV & Test Lead for Enterprise Apps (Hybrid)

Straumann Group; León; Híbrido; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Straumann Group seeks an experienced CSV and Test Management Lead to drive validated software solutions like SAP and Salesforce within Global Business Applications. You will lead CSV strategy, test plans, and validation activities across the lifecycle, ensuring regulatory compliance and high-quality delivery.

The role requires 10+ years in CSV/QM, strong knowledge of 21 CFR Part 11 and GAMP 5, and excellent stakeholder collaboration.

Formación

• 10+ years in CSV, QM, Test and Project Management with leadership experience.
• Strong knowledge of 21 CFR Part 11, GAMP 5 and Annex 11 requirements.
• Experience with validation documentation and audits in regulated industries.
• Experience integrating SAP/Suite ERP projects into validated environments.

Responsabilidades

• Lead validation documentation across SDLC with stakeholders.
• Define and manage CSV strategy, test plans and traceability matrices.
• Provide CSV guidance to project teams and QA/compliance functions.
• Drive continuous improvement of CSV standards and regulatory alignment.
• Lead Test Management for Business Applications and SAP-related initiatives (e.g., S/4HANA).
• Coordinate with Quality Assurance, Test Management and Compliance teams for aligned deliverables.
• Collaborate with IT and business stakeholders to ensure compliance and project quality.

Conocimientos

CSV

Test Management

Leadership

Stakeholder Management

GxP knowledge

Regulatory compliance

Quality Assurance

English Proficiency

Educación

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

Herramientas

SAP

Salesforce

S/4HANA / ERP Systems

Descripción del empleo

Straumann Group seeks an experienced CSV and Test Management Lead to drive validated software solutions like SAP and Salesforce within Global Business Applications. You will lead CSV strategy, test plans, and validation activities across the lifecycle, ensuring regulatory compliance and high-quality delivery.

The role requires 10+ years in CSV/QM, strong knowledge of 21 CFR Part 11 and GAMP 5, and excellent stakeholder collaboration.