CSV & Test Management Lead - Hybrid/Remote

Straumann Group; Segovia; Híbrido; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

Straumann Group in Madrid (hybrid) seeks a Senior CSV and Test Management Lead to drive the validation of SAP, Salesforce and other enterprise applications and enable global test management capabilities across the Global Business Applications team.

You will lead validation documentation, guide project teams, improve CSV standards, and partner with QA, Compliance and IT to ensure regulatory compliance (GxP, 21 CFR Part 11, GAMP 5, Annex 11).

Formación

• 10+ years in CSV, QM, Test and Project Management.
• 2+ years in a leadership role.
• Strong knowledge of GxP regulations (21 CFR Part 11, GAMP 5, Annex 11).
• Experience with SAP and other enterprise applications.
• Excellent communication and stakeholder management.

Responsabilidades

• Validate and review validation documentation (SDLC) with stakeholders, including validation strategy, test plans, user requirements, FDs, SOPs, and qualification documents.
• Provide CSV guidance to implementation/update project teams.
• Improve CSV standards in line with regulatory changes across IT and QA.
• Define, drive and implement Test Management for Business Applications and major initiatives like S/4HANA.
• Coordinate with QA, Compliance, and IT to align deliverables as CSV guidelines.
• Lead local CSV/QA reps to meet global CSV compliance requirements.
• Train and coach stakeholders on CSV standards and test approaches.
• Collaborate with IT and business teams to ensure compliance and project quality.
• Participate in internal/external audits as needed.

Conocimientos

CSV

QM

Test management

Project management

Leadership

GxP regulations

Stakeholder management

Communication skills

English fluency

Educación

Bachelor's/Master's in CS/IS/QM

Herramientas

SAP

Salesforce

Enterprise Applications

Descripción del empleo

Straumann Group in Madrid (hybrid) seeks a Senior CSV and Test Management Lead to drive the validation of SAP, Salesforce and other enterprise applications and enable global test management capabilities across the Global Business Applications team.

You will lead validation documentation, guide project teams, improve CSV standards, and partner with QA, Compliance and IT to ensure regulatory compliance (GxP, 21 CFR Part 11, GAMP 5, Annex 11).