Pharmaceutical Quality Lead

2 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time

Job Summary

Sobi is a global biopharmaceutical company transforming the lives of people with rare and debilitating diseases. We are seeking a Pharmaceutical Quality Lead to oversee the quality interface and cross-functional relationships with Sobi stakeholders.

About the Role

This position requires a deep understanding of GMP requirements and experience working in a global and complex environment. Strong leadership skills and ability to influence external suppliers are essential.

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 offer a competitive compensation package, opportunities for professional growth, and a collaborative work environment that values diversity and inclusion.



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