Descripción de la oferta
Job PurposeThis 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.Es esencial asegurarse de que cumple con los requisitos como solicitante para este puesto; por favor, lea atentamente la información a continuación.Main Tasks And ResponsibilitiesManage 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) guidanceContinuous 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 StrategyPartner with Quality Assurance, Test Management and Compliance teams to align deliverables as CSV guidelinesCoordinate local CSV and QA representatives to fulfill global CSV Compliance requirements.Provide Training, guidance and coaching to all stakeholders for CSV standards, Test approachesCollaborate 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.EducationBachelor's or master's degree in computer science, Information Systems, QM or related field and/or related working experience.Experience & Personal Attributes10+ 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 deliverablesFamiliar with several software development methodologies and the capability to adapt them for CSVStrong 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)Work locationsStraumann Group offices in Madrid/Wroclaw/Curitiba - Hybrid, with 2 remote working days/weekRemote from Spain with some travel for business meetings to Madrid expectedAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.Employment TypeFull TimeAlternative LocationsSpain : MadridBrazil : CuritibaPoland : GdanskPoland : WroclawSpain : AlbaceteSpain : AlcobendasSpain : AlicanteSpain : AlmeríaSpain : ArabaSpain : AsturiasSpain : BadajozSpain : BarcelonaSpain : BilbaoSpain : BurgosSpain : CantabriaSpain : CastellóSpain : Ciudad RealSpain : CuencaSpain : CáceresSpain : CádizSpain : CórdobaSpain : GipuzkoaSpain : GironaSpain : GranadaSpain : GuadalajaraSpain : HuelvaSpain : HuescaSpain : Illes BalearsSpain : JaénSpain : La CoruñaSpain : La RiojaSpain : Las PalmasSpain : LeónSpain : LleidaSpain : LugoSpain : MendaroSpain : MurciaSpain : MálagaSpain : NavarraSpain : OurenseSpain : PalenciaSpain : PontevedraSpain : SalamancaSpain : Santa Cruz de TenerifeSpain : SegoviaSpain : SevillaSpain : SoriaSpain : TarragonaSpain : TeruelSpain : ToledoSpain : ValenciaSpain : ValladolidSpain : ZamoraSpain : ZaragozaSpain : ÁvilaTravel Percentage0 - 10%Requisition ID20070#J-18808-Ljbffr
