Regulatory Compliance Expert

2 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time

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 Role

This 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:
  1. Manage quality issues, audits, and change requests.
  2. Oversee product release, supplier qualifications, and quality technical agreements.
  3. Implement and maintain quality risk assessments and KPIs.
  4. Lead quality initiatives and act as a quality representative in projects.
Qualifications

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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