Management of the Regulatory Support and Quality Compliance departments
Qualified person according to § 15 AMG
Maintaining and further developing the quality assurance systems for medicinal products, medical devices and APIs at the Friedberg site
Management and development of subordinate employees
Market release of finished medicinal products and APIs
Harmonization, centralization and streamlining of plant-internal processes and systems related to QMS/IMS
Independent establishment and further development of FDA, EU GMP, MDD, MDR, ISO 13485 and ISO 9001-compliant Q systems
Contact person for audits and inspections, including preparation, follow-up and implementation
Approval of SOPs and other GMP documents
Creating and negotiating quality agreements with customers and suppliers
Ensuring compliance with global specifications
Planning the management review (incl. follow-up of measures)
Continuous further development of the document management system
Ensuring the documentation of the required processes for the QM system
Ensuring awareness of legal/regulatory requirements and the QM system throughout the organization
Continuous evaluation of national and international laws and standards, guidelines from the GMP and medical device environment as well as the implementation of specifications from Fresenius Global Quality Management and Divisional Quality Management in local processes
Responsible implementation and support of projects
Completed studies in the fields of chemistry, pharmacy, biology, biotechnology or comparable
Qualification as a Qualified Person according to § 15 AMG
Approx. 5 years of professional experience
Extensive knowledge of pharmaceutical and medical device law and related legal areas, FDA-regulated environment and ISO 9001 and ISO 13485 regulations
Experience in manufacturing, quality control or quality assurance of sterile drugs and/or medical devices
High sense of responsibility and reliability
Confident and professional demeanor
High analytical and evaluation skills
Very good communication and cooperation skills
Process and quality orientation and affinity for automated processes
As long as the job ad is online, you can apply quickly and easily.
At Fresenius, we are convinced that combining different perspectives, opinions, experiences, cultures and values enables us to harness the potential that will make us even more successful. All job applicants are welcome.
All terms used in this job advertisement to denote persons refer to all genders equally.
When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.