Regulatory Compliance Expert
2 days ago
Job Details
Sobi is a specialized biopharmaceutical company committed to making a positive impact on the lives of patients with ultra-rare diseases. We are seeking a Regulatory Compliance Expert to join our team.
About the RoleThis position is responsible for ensuring compliance with GMP & GDP regulations and Sobi's Quality System. The ideal candidate will have a deep understanding of GMP requirements and experience working in a global and complex environment.
Key Responsibilities:- Manage quality issues, audits, and change requests.
- Oversee product release, supplier qualifications, and quality technical agreements.
- Implement and maintain quality risk assessments and KPIs.
- Lead quality initiatives and act as a quality representative in projects.
To be successful in this position, you should have a 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 operations 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.
We value diversity and inclusion and offer a competitive compensation package, opportunities for professional growth, and a collaborative work environment.
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