Senior Quality Assurance Manager

4 days ago


Stockholm, Stockholm, Sweden Sobi group Full time

About the Role

We are seeking a highly skilled Senior Quality Assurance Manager to lead our quality assurance efforts in analytical activities. As a key member of our team, you will be responsible for ensuring compliance with GMP guidelines and regulatory requirements.

Key Responsibilities:

  • Act as GMP specialist for analytical activities, including stability studies.
  • Ensure correct implementation of GMP guidelines in QA Analytics processes.
  • Approve deviations, CAPAs, change controls, and manage internal QA investigations.
  • Oversee analytical method validations, tech transfers, and stability studies.
  • Liaise with Global Regulatory Affairs/CMC on analytical quality issues.
  • Author, review, and approve SOPs and related documentation.

Requirements:

  1. University degree (min. 4 years) in Chemistry, Biology, Biotechnology, or related field.
  2. 10+ years of QA experience in analytical science within a GMP environment.
  3. Strong understanding of regulatory guidelines, method validation, and product specifications.
  4. Proven experience managing deviations, CAPAs, and interactions with external stakeholders.
  5. Broad knowledge of analytical chemistry and bioassays.
  6. Fluent in English (written and spoken).

About Us

Sobi is a global biopharmaceutical company dedicated to developing and delivering innovative therapies for rare diseases. Our focus is on haematology, immunology, and specialty care. We value work-life balance and recognize its importance in driving employee satisfaction and productivity.



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