Quality Assurance Manager
6 days ago
The Quality Supplier Manager plays a pivotal role in ensuring the quality oversight of external suppliers involved in manufacturing activities for our products. As the single point of contact, this position is responsible for guaranteeing compliance with current GMP & GDP regulations, the Quality Technical Agreement, and Sobi's procedures and policies to enhance product supply to consumers and support business growth.
Main 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:
To be successful in this position, you should have a deep understanding of GMP & GDP requirements. You must be comfortable working in a global and complex environment, possess strong interpersonal and leadership skills, and be able to influence external suppliers in a cross-functional setting. Additionally, you should have excellent collaborative skills to develop strong relationships within Sobi and with external suppliers.
A degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science is required, including courses in inorganic, organic, analytical, physical, and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology, toxicology, microbiology, and pharmacognosy. Furthermore, more than 10 years of experience within pharmaceutical or biotech products and over 5 years in QA operation or external quality including supplier quality management are necessary. In-depth knowledge of GMP requirements from FDA, EMEA, or other health authorities is also essential.
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