
Senior Quality Assurance Manager
4 days ago
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:
- University degree (min. 4 years) in Chemistry, Biology, Biotechnology, or related field.
- 10+ years of QA experience in analytical science within a GMP environment.
- Strong understanding of regulatory guidelines, method validation, and product specifications.
- Proven experience managing deviations, CAPAs, and interactions with external stakeholders.
- Broad knowledge of analytical chemistry and bioassays.
- 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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