Senior Quality Manager

5 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time

At Sobi, we are committed to the quality of our products and the trust of our customers. We are currently seeking a Senior Quality Manager to join our team in Stockholm.

Job Description:

The Senior Quality Manager will be responsible for overseeing the quality oversight of external suppliers in charge of manufacturing activities for our product. This includes ensuring compliance with current GMP & GDP regulations, the Quality Technical Agreement, and Sobi's procedures and policies.

The role requires strong leadership skills, excellent communication skills, and the ability to influence external suppliers in a cross-functional environment. The ideal candidate will have a great understanding of GMP & GDP requirements and experience in QA operations or external quality including supplier quality management.

Key Responsibilities:

  • Serve as the primary contact for all quality-related activities with external suppliers.
  • 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 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 or biotech product development.
  • 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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