Job Purpose

¿Es este su próximo empleo? Descúbralo leyendo la descripción completa a continuación y no dude en enviar su candidatura.
This is a great opportunity to apply your leadership and expertise in pursuit of our mission to become the most customer-focused and innovative oral care company in the world. We are seeking an experienced CSV and Test Management Lead to drive the delivery of validated software solutions like SAP, Salesforce and other enterprise Applications and enable Global Test Management and capabilities for Straumann’s Global Business Applications department. The ideal candidate will bring deep CSV and Test Management expertise for Enterprise Business Applications like SAP, etc.

Main Tasks And Responsibilities

Manage and review all levels of validation documentation (internal or external SDLC) in collaboration with all stakeholders
Including Validation (Strategy) & Test Plans, User Requirements, Functional, Configuration, Installation Specifications, SOP’s and Qualification Documents like Test Specifications & records. Traceability Matrices, Risk Analysis, Validation Reports, etc.

Provide implementation or update project teams with computerized systems validation (CSV) guidance

Continuous Improvement of CSV standards, considering best practices and regulatory changes to maintain compliance and improve validation processes in alignment with IT and QA departments.

Key role for defining, driving and implementation of Test Management for Business Application and other major initiatives like S/4HANA in alignment with Application Lifecycle Management Strategy

Partner with Quality Assurance, Test Management and Compliance teams to align deliverables as CSV guidelines





Coordinate local CSV and QA representatives to fulfill general CSV Compliance requirements.

Provide Training, guidance and coaching to all stakeholders for CSV standards, Test approaches

Collaborate with functional teams in IT across SAP and other Business Application stakeholders and all relevant business representatives to ensure compliance and/or project quality.

Participate in internal and external audits if needed.

Requirements Needed
Education

Bachelor's or master's degree in computer science, Information Systems, QM or related field and/or related working experience.

Experience & Personal Attributes

10+ years of experience in CSV, QM, Test and Project Management, with at least 2 years in a leadership role.

Strong expertise in GxP requirements and guidelines like 21 CFR Part 11 regulations, GAMP 5 and Annex11 requirements for computerized systems.

Understanding, adapting and establishing GxP regulations, CSV and documentation best practices in regulated industries.

Strong Project- & Test management skills with the ability to adapt also solution-oriented compliance deliverables

Familiar with several software development methodologies and the capability to adapt them for CSV

Strong communication and stakeholder management skills, with the ability to build and maintain strong relationships across the organization and with external partners. xqbhyrx





Capacity to face and adapt to challenges to overcome them (resilience)

Fluent English spoken and written, other languages are an asset (DE)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type
Full Time

Work locations

Straumann Group offices in Madrid/Wroclaw/Curitiba - Hybrid, with 2 remote working days/week

Remote from Spain with some travel for business meetings to Madrid expected

Alternative Locations

Spain : Madrid

Brazil : Curitiba

Poland : Gdansk

Poland : Wroclaw

Spain : Albacete

Spain : Alcobendas

Spain : Alicante

Spain : Almería

Spain : Araba

Spain : Asturias

Spain : Badajoz

Spain : Barcelona

Spain : Bilbao

Spain : Burgos

Spain : Cantabria

Spain : Castelló

Spain : Ciudad Real

Spain : Cuenca

Spain : Cáceres

Spain : Cádiz

Spain : Córdoba

Spain : Gipuzkoa

Spain : Girona

Spain : Granada

Spain : Guadalajara

Spain : Huelva

Spain : Huesca

Spain : Illes Balears

Spain : Jaén

Spain : La Coruña

Spain : La Rioja

Spain : Las Palmas

Spain : León

Spain : Lleida

Spain : Lugo

Spain : Mendaro

Spain : Murcia

Spain : Málaga

Spain : Navarra

Spain : Ourense

Spain : Palencia

Spain : Pontevedra

Spain : Salamanca

Spain : Santa Cruz de Tenerife

Spain : Segovia

Spain : Sevilla

Spain : Soria

Spain : Tarragona

Spain : Teruel

Spain : Toledo

Spain : Valencia

Spain : Valladolid

Spain : Zamora

Spain : Zaragoza

Spain : Ávila

Travel Percentage
0 - 10%

#J-18808-Ljbffr

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