GMS Documentation Control Lead

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).