
Senior Pharmaceutical Quality Assurance Manager
7 hours ago
About Sobi
Sobi is a global biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. Our mission is to provide reliable access to innovative medicines in areas such as haematology, immunology, and specialty care.
As a key player in the industry, we are committed to our core values: Care, Ambition, Urgency, Ownership, and Partnership. We believe that by working together with patients, partners, and stakeholders, we can create solutions that meet the needs of those affected by rare diseases while driving sustainable growth.
About the Role
We are seeking an experienced Pharmaceutical Quality Assurance Manager to join our team. As a key member of our quality assurance function, you will be responsible for ensuring compliance with GMP & GDP regulations and Sobi's quality system. Your primary contact point for all quality-related activities with external suppliers, you will oversee product release, supplier qualifications, and quality technical agreements.
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.
About Us
Sobi is a global company with over 1,800 employees in more than 30 countries. We are committed to the societies where we operate and strive to make a positive impact on the lives of people with rare diseases.
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Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeAbout SobiSobi 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...
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