Risk Manager (m/f/d)

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.

Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Location / Division Specific Information :

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage.

Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics.

Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.

Position Overview :

The initiates, coordinates and monitors all Risk Management activities related to EliA products in Freiburg in collaboration with other QM members and other departments, including our Uppsala site in Sweden.

A Day in the Life :

• Implementation of ISO 14971
• Release of all Risk Management procedures, instruction and forms
• Training of the Risk Management process as needed
• Support of New Product Development, Product Care and Compliance projects
• Support all activities where risk management are needed (CAPA, NCs, validation, QMS)
• Act as Chair of the IDD Risk Management Board : Facilitates / supports Risk Management meetings in order to evaluate risks and update risk files;

Represents the CoE Autoimmunity and coordinates all RM related projects for Freiburg in the ImmunoDiagnosticsDivision (IDD)

• Coordinates all Risk Management Process interfaces
• Drives the ongoing Risk Management Remediation Project
• Risk Management Reporting

Keys to Success :

• University degree in natural or pharmaceutical science (health science, biology, biochemistry area) with relevant professional experience
• Strong theoretical and practical know how in Risk Management (ISO 14971)
• Good Quality management background (ISO 13485, QSR, MDR, IVDR)
• Many years of experience in production within Medical Devices, IVD or pharma environment
• People management, communication and problem solving skills
• Experienced in Project Management
• Independent and well-structured approach of tasks
• Excellent spoken and written language skills in German and English
• Auditor certification is a plus

What we offer :

• Employment with an innovative, future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation
Vor 30+ Tagen