The Quality Supplier Manager role is a key position within our organization, responsible for overseeing the quality of external suppliers in charge of manufacturing activities for our products. This individual will act as a single point of contact with external suppliers, ensuring compliance with GMP & GDP regulations, Quality Technical Agreements, and Sobi's procedures and policies to enhance product supply and support business growth.
Key Responsibilities:
* Serve as 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:
* A deep understanding of GMP & GDP requirements is essential for success in this position. The ideal candidate will be comfortable working in a global and complex environment, possess excellent interpersonal and leadership skills, and be able to influence external suppliers in a cross-functional setting.
* A degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science is required, with courses in inorganic, organic, analytical, physical, and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology, and toxicology.
* At least 10 years of experience in the pharmaceutical industry, including QA operations or external quality management, is necessary. Strong knowledge of GMP requirements from FDA, EMEA, or other health authorities is also required.
* Fluency in English, both written and spoken, is essential for effective communication with internal stakeholders and external partners.
About Sobi:
Sobi is a global biopharmaceutical company dedicated to providing innovative medicines for patients with rare and debilitating diseases. With over 1,800 employees in more than 30 countries, we are committed to transforming lives through our work.
We offer a collaborative and team-oriented environment, opportunities for professional growth, diversity and inclusion, and a competitive compensation package that supports the health and happiness of our staff.