QA Analytical Specialist

About the role

Global Quality plays a key role in making sure our medicines meet internal standards, regulatory expectations, and the commitments in our registration files. As an independent quality organisation, we bring the expertise to deliver on these commitments—while continuously strengthening our capabilities, developing our people, and evolving our quality system to support the business as we grow.

As QA Analytical Specialist, you’ll be the quality partner for analytical activities and stability studies for products where Sobi is the MAH. You’ll ensure GMP-compliant methods and data support reliable release and stability testing for both clinical and commercial supply—working closely with internal stakeholders and external partners to keep quality, compliance, and patient impact at the centre of everything we do.

It is a Hybrid role and can be based in either Stockholm or Basel, reporting to Head of Quality Product Lifecycle & Clinical Supply.

Key Responsibilities

• Coordinator and Quality approver for deviations, CAPA and change controls.
• QA-approver for GMP-related analytical activities, e.g. validation and technology transfer of analytical methods used for in-process control, release and stability studies.
• Performance of quality evaluation of CLOs.
• QA contact for CLOs
• Provide Quality Assurance for stability studies for products where Sobi is the MAH, including approving plans and protocols.
• Perform QA review and approval of extension of expiry date of critical analytical material, including but not limited to reference standards and control samples.
• Perform QA review and approval of product specifications.
• Give support to Global Regulatory Affairs / CMC in analytical quality issues for variations and market expansions.
• Act as a representative of Global Quality and provide QA analytical guidance to support projects in order to ensure compliance with GMP
• Manage Quality Technical Agreements with CLOs.
• Author, review and approve SOPs and related documentation related to the position.