Quality Risk Manager
vor 4 Wochen
Thermo Fisher Scientific Inc. stands as the global leader in scientific services, generating an impressive annual revenue of around $40 billion. Our mission is to empower our clients in making the world healthier, cleaner, and safer. We support our customers in various domains, including life sciences research, complex analytical challenges, laboratory productivity, patient health diagnostics, and the development of transformative therapies. Our dedicated global workforce of over 100,000 professionals provides an unmatched blend of innovative technologies, purchasing convenience, and pharmaceutical services through our renowned brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Division Specific Information:
Phadia is recognized as the premier provider of fully automated blood analysis systems for allergy and autoimmune disorders. Our cutting-edge products set global benchmarks, assisting healthcare professionals in delivering swift and accurate diagnoses, thereby aiding patients at critical early stages. Phadia GmbH, located in Freiburg, operates as the German branch of the Immunodiagnostics division of Thermo Fisher Scientific, a worldwide entity dedicated to the development, manufacturing, and distribution of in vitro diagnostics in the allergy and autoimmune diagnostics sector. Our clientele anticipates a consistently high standard of quality from our offerings, which we uphold through innovative biochemical and medical technology solutions, alongside a team of highly skilled and motivated personnel.
Position Overview:
The Risk Manager will initiate, coordinate, and oversee all Risk Management activities pertaining to EliA products in Freiburg, collaborating closely with other Quality Management members and various departments, including our Uppsala site in Sweden.
Key Responsibilities:
- Implement ISO 14971 standards.
- Release all Risk Management procedures, instructions, and forms.
- Provide training on the Risk Management process as required.
- Support New Product Development, Product Care, and Compliance initiatives.
- Assist in all activities necessitating risk management (CAPA, NCs, validation, QMS).
- Serve as Chair of the IDD Risk Management Board, facilitating and supporting Risk Management meetings to assess risks and update risk files; represent the CoE Autoimmunity and coordinate all RM-related projects for Freiburg within the ImmunoDiagnostics Division (IDD).
- Coordinate all interfaces related to the Risk Management Process.
- Drive the ongoing Risk Management Remediation Project.
- Conduct Risk Management Reporting.
- University degree in natural or pharmaceutical sciences (health science, biology, biochemistry) with relevant professional experience.
- Strong theoretical and practical expertise in Risk Management (ISO 14971).
- Solid background in Quality Management (ISO 13485, QSR, MDR, IVDR).
- Extensive experience in production within Medical Devices, IVD, or pharmaceutical environments.
- Proficient in people management, communication, and problem-solving skills.
- Experienced in Project Management.
- Independent and well-organized approach to tasks.
- Excellent verbal and written communication skills in both German and English.
- Auditor certification is an advantage.
- Employment with an innovative and forward-thinking organization.
- Exceptional career and development opportunities.
- Company pension scheme and additional benefits.
- A vibrant company culture that emphasizes integrity, intensity, involvement, and innovation.
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