Descripción de la oferta
Job Purpose
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 stakeholdersIncluding 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 global 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.
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
