Aktuelle Jobs im Zusammenhang mit Risk Assessment Manager - Freiburg, Baden-Württemberg - Thermo Fisher Scientific
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Risk Assessment Manager
vor 2 Monaten
Thermo Fisher Scientific Inc. stands as the global leader in scientific services, boasting an impressive annual revenue of around $40 billion. Our mission is to empower our clients in making the world a healthier, cleaner, and safer place. We support our customers in various fields, including life sciences research, analytical challenges, laboratory productivity, diagnostics, and the development of transformative therapies. Our dedicated global workforce of over 100,000 professionals delivers an unparalleled mix 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, aiding clinicians in delivering swift and accurate diagnoses, thereby assisting patients at critical early stages. Phadia GmbH, located in Freiburg, is the German branch of the Immunodiagnostics division of Thermo Fisher Scientific, a worldwide entity that specializes in the development, manufacturing, and distribution of in vitro diagnostics for allergy and autoimmune diagnostics. Our clientele anticipates consistent reliability and high-quality standards from our offerings, which we uphold through innovative biochemical and medical technology solutions, complemented by our highly skilled and motivated workforce.
Position Overview:
The Risk Manager will initiate, coordinate, and oversee all Risk Management activities associated with EliA products in Freiburg, collaborating closely with other Quality Management team members and various departments, including our site in Sweden.
Key Responsibilities:
- Implement ISO 14971 standards.
- Develop and release all Risk Management procedures, instructions, and forms.
- Conduct training sessions 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 documentation; represent the Center of Excellence in Autoimmunity and coordinate all Risk Management-related projects for Freiburg within the ImmunoDiagnostics Division.
- Coordinate all interfaces related to the Risk Management Process.
- Drive the ongoing Risk Management Remediation Project.
- Prepare Risk Management reports.
- 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 the Medical Devices, IVD, or pharmaceutical sectors.
- 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 advantageous.
- 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.
