* Full-time
Company Description
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
At Sobi, the work we do every day redefines the standards of care and transforms the lives of people living with rare diseases.
As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.
We are committed to an inclusive, sustainable, and flexible workplace that fosters growth and development.
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:
1. Serve as the primary contact for all quality-related activities with external suppliers.
2. Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
3. Oversee product release, supplier qualifications, and quality technical agreements.
4. Implement and maintain quality risk assessments and KPIs.
5. Manage quality issues, audits, and change requests.
6. 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 the ability to influence external suppliers in a cross-functional environment to foster decisions and propose solutions. Furthermore, you have great collaborative skills to develop strong relationships within Sobi and with the external suppliers.
1. High level education (university degree or similar) within relevant areas such as pharmaceutical, biotech, or life science.
2. More than 10 years of experience within pharmaceutical or biotech products. More than 5 years of experience in QA operations or external quality including supplier quality management (GMP, GDP).
3. In-depth understanding of GMP requirements of FDA, EMEA, or other health authorities.
4. Strong understanding of risk assessment and risk management fundamentals/tools.
5. Excellent verbal and written communication skills.
6. Fluently spoken and written English.
Here at Sobi, we live by our core values: Care, Ambition, Urgency, Ownership, and Partnership!
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