Descripción de la oferta
In this role you lead CSV and Test Management for Straumann’s Global Business Applications, driving validated ERP and enterprise solutions like SAP and Salesforce. You will shape CSV standards, oversee lifecycle documentation, and support global compliance through training and audits. You will collaborate with IT, QA, and business stakeholders during a digital transformation and major initiatives such as S/4HANA. This is a hands-on leadership position with cross-functional impact and regulatory accountability.Manage validation documentation across SDLC with stakeholders (validation strategy, test plans, user requirements, functional/configuration specs, SOPs, test records)Provide CSV guidance to implementation or update project teamsContinuously improve CSV standards to align with IT and QA and regulatory changesDefine, drive and implement Test Management for Business Applications and initiatives like S/4HANACoordinate with QA, Compliance, and Test teams to align deliverables with CSV guidelinesCoordinate local CSV and QA representatives to meet global CSV compliance requirementsProvide training and coaching on CSV standards and testing approachesCollaborate with SAP and other Business Application stakeholders to ensure compliance and project qualityParticipate in internal and external audits as needed10+ years in CSV, QM, Test and Project Management with at least 2 years in a leadership roleStrong expertise in GxP, 21 CFR Part 11, GAMP 5 and Annex11Experience establishing CSV/documentation best practices in regulated environmentsStrong project and test management skills with ability to deliver compliance-focused outputsFamiliarity with multiple software development methodologies and adapting them for CSVExcellent communication and stakeholder management skillsResilience and adaptability to challengesFluent English; additional language (German) is an assetstrong communicationleadershipCSV (Computerized Systems Validation)GxP compliance21 CFR Part 11
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