
Quality Assurance Lead
5 hours ago
We are a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Our mission is to provide reliable access to innovative medicines in the areas of haematology, immunology, and specialty care.
Job Overview:The Quality Assurance Lead will be responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders. This includes ensuring compliance with GMP & GDP regulations, the Quality Technical Agreement, and Sobi's procedures and policies.
The role requires strong leadership skills, excellent communication skills, and the ability to influence external suppliers in a cross-functional environment. The ideal candidate will have a great understanding of GMP & GDP requirements and experience in QA operations or external quality including supplier quality management.
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.
Requirements:
- Degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science, including courses in inorganic, organic, analytical, physical, and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology, and toxicology.
- More than 10 years of experience within pharmaceutical or biotech product development.
- 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.
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