
External Quality Assurance Manager for Pharmaceuticals
14 hours ago
About Sobi
Sobi is a global leader in the development and commercialization of innovative treatments for rare and debilitating diseases. Our company operates in over 30 countries, employing over 1,800 talented individuals who share our passion for making a difference.
We value diversity and inclusion in our workplace and strive to create an environment that fosters collaboration, innovation, and growth. If you are a driven and motivated professional looking to contribute to a dynamic team, we would love to hear from you.
About the Role
We are seeking an experienced External Quality Assurance Manager for Pharmaceuticals to join our team. This role involves overseeing product release, supplier qualifications, and quality technical agreements to ensure compliance with GMP & GDP regulations and Sobi's quality system.
Your Key Responsibilities
- 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, biotech products. More than 5 years of 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.
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