Senior Consultant Validation & Compliance

Fresenius is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In fiscal year 2024, Fresenius generated €21.5 billion in annual revenue with around 175,000 employees (excluding Fresenius Medical Care).

Main tasks 

§  Consulting and design within given processes & technologies 

§  Consulting, implementation or development of strategic processes, technologies and services of large-scale and medium to high complexity*, incl. integrated sub-processes 

§  Support for the detailed analysis as well as design in the specification part of the value chain and transfer of the user requirements into a reliable working concept 

§  Contribution to definition of scope and planning of projects, services and solutions 

§  Preparation of cost estimates for process and technology-related sub-projects and services of medium to high complexity* 

§  Responsible for the design of solution or process architectures 

§  Execution and/or supervision of the realization of concepts, and installation of operational measures for quality assurance 

§  Second and third-level support for process and technology-related subjects  

§  Conducts activities in line with given process landscapes and regulations 

§  Risk assessments in his/her area of responsibility and implementation or suggestion of appropriate countermeasures  

§  Identification & initiation of continuous service and process improvements in medium to highly complex* business environments 

§  Represents team in board meetings and working groups as assigned by Line Management 

§  If applicable: functional leadership and responsibility within area of expertise as assigned by Line Manager 

§  Collaboration in international business contexts including virtual teams 

§  Collaboration with internal and external stakeholders 

§  Representation of the organization to cross-functional stakeholders, clients and external groups 

§  Communication as equal partner with stakeholders even above his/her own level 

Additions / Details: 

§ Required 10+ yrs experience and 7+ yrs relevant experience. 

§  Development of validation and qualification concepts, considering customer requirements and legal regulations as preparation for the creation of validation and qualification (master) plans. 

§  Competent, timely, and cost-effective management and execution of projects in the areas of computer system validation (CSV) and qualification of IT infrastructure. 

§  This project work includes the creation and quality assurance of project content, such as the preparation of risk analyses, review of technical specifications and test strategies, as well as the creation of traceability matrices. 

§  Planning and coordination of project team members to ensure validation and qualification activities in an international environment. 

§  Planning and quality assurance of data migration projects. 

§  Planning and execution of IT supplier qualification activities (e.g., audits). 

§  Planning and delivery of training sessions, in the respective area of expertise. 

§  Coordination with internal and external stakeholders, including suppliers, to achieve a validated and qualified state. 

§  Support in the development of departmental budgets, monitoring of assigned budgets, and representation of the organization to cross-functional stakeholders, business partners, and external groups. 

Amit Kumar

Amit.Singh1@fresenius.com

*By applying for a job offer, you agree that only the country-specific labor law of the respective legal entity will be applied to the application process.