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. As part of our digital transformation journey and business growth strategy, you will play a key role in contributing to major initiatives across the organization. You will report to the Head of Global Business Applications Processes, Toolchain, and Delivery. 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/4 HANA 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 Gx P requirements and guidelines like 21 CFR Part 11 regulations, GAMP 5 and Annex11 requirements for computerized systems. Understanding, adapting and establishing Gx P 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) Work location Straumann Group offices in Madrid/Wroclaw - Hybrid, with 2 remote working days/week. Employment Type Full Time 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% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability. #J-18808-Ljbffr
