
Quality Oversight Director for External Partners
6 days ago
Job Summary:
The Quality Supplier Manager is responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders. This position requires strong leadership and communication skills, as well as an in-depth understanding of GMP requirements.
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.
Qualifications:
- Degree of at least 160 university credits in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science.
- More than 10 years of experience within pharmaceutical, biotech products, and QA operations or external quality including supplier quality management.
- 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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