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Client:
Sobi
Location:
Job Category:
Other
Job Reference:
79f5a0223600
Job Views:
4
Posted:
10.02.2025
Expiry Date:
27.03.2025
Job Description:
The Quality Supplier manager is responsible for a wide range of activities related to the Quality oversight of external suppliers in charge of the manufacturing activities for a product. Acting as a single point of contact with the external supplier, the Quality Supplier manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations, the Quality Technical Agreement and with Sobi procedures and policies to enhance the product supply of medicines to consumers and to support the fast growth of Sobi. This role is also responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders.
The role is a temporary contract until December 2025.
Key Responsibilities:
* Serve as the primary contact for all quality-related activities with external suppliers.
* Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
* Oversee product release, supplier qualifications, and quality technical agreements.
* Implement and maintain quality risk assessments and KPIs.
* Manage quality issues, audits, and change requests.
* Lead quality initiatives and act as a quality representative in projects.
Qualifications:
In order to be successful in this position you should have a great understanding of the GMP & GDP requirements. You are comfortable in a global and complex environment; have interpersonal and leadership skills with ability to influence external Suppliers in a cross-functional environment to foster decisions and to propose solutions. Furthermore, you have great collaborative skills to develop strong relationships within Sobi but also with the External Suppliers.
* High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science.
* More than 10 years of experience within pharmaceutical, biotech product. More than 5 years experience in QA operation or external quality including supplier quality management (GMP, GDP).
* In-depth understanding of GMP requirements of FDA; EMEA or other Health Authorities.
* Strong understanding of risk assessment and risk management fundamentals/tools.
* Excellent verbal and written communication skills.
* Fluently spoken and written English.
Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership!
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