**Your tasks:** + Develop, implement, and continually improve global documentation management processes, controls, and tools to meet regulatory and business requirements, ensuring harmonized implementation across all regions. + Provide oversight for the Global Management System (GMS) document control, retention, and change control processes, including eDMS tools. Act as process owner for documentation management and associated tools. + Lead projects to enhance eDMS platforms (e.g., QDOK), consolidate legacy systems, and onboard business subsidiaries such as NxStage and Xenios onto the GMS platform. + Manage and analyze KPIs and metrics for documentation processes; prepare reports and presentations for management reviews and stakeholders. + Responsible for the functional management of the GMS documentation office, ensuring provision of services and support to the Organisation as applicable + Liaise with internal stakeholders, including Management System representatives, regulatory units, business units, and operational teams, to ensure alignment with GMS objectives. + Ensure the maintenance and continuous improvement of electronic document control systems, including validation, user training, troubleshooting, and user management. + Lead periodic reviews of controlled documents, manage document change requests, and oversee translation and archiving of regulatory records. + Design and deliver training materials to ensure role-based qualifications in documentation processes. + Monitor and implement new or changed external regulatory requirements, ensuring system compliance and integration with GMS tools. + Support external audits by hosting, leading, and following up as necessary; manage CAPAs, improvement actions, and related projects. **Your profile:** + University degree in a scientific or technical discipline, with experience in quality management systems for medical devices, pharmaceuticals, or healthcare services. + Minimum of 5 years of professional experience in the medical device or pharmaceutical industry, preferably in a multinational and/or international environment. + Experience in managing teams, setting priorities, and driving accountability. + Strong communication and stakeholder management skills, promoting open, transparent, and trustful relationships. + In-depth knowledge of applicable normative and legal requirements (e.g., ISO 13485, ISO 9001, MDSAP, GxP) and familiarity with business processes in the medical device/pharmaceutical industry. + Advanced skills in IT systems (e.g., MS Office, SharePoint, eDMS) and understanding of data security fundamentals. + Excellent moderation and presentation skills; qualification as an auditor is a plus. + Fluent in English (spoken and written); additional languages are a plus. + Flexibility to travel and willingness to adapt to new responsibilities and work across time zones. **Our offer to you:** + There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert and how much experience you bring with you - for your professional future with meaning: + The opportunity to work on a mobile basis + Whether in front of or behind the scenes - you will help to make better and better therapy available to more and more people around the world + Individual opportunities for self-determined career planning and professional development + A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together + A large number of committed people with a wide range of skills, talents and experience + The benefits of a successful global corporation with the collegial culture of a medium-sized company The position can be filled in Bad Homburg (Germany), Huthwaite (UK) or Waltham (North America).