Job Information
Fresenius Medical Care North America GMS Documentation Control Lead (m/f/d) in Bad Homburg, Germany
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).