QA Analytical Specialist Lead

QA Analytical Specialist Lead

Sobi

Stockholm, Sweden

Job Description

We are seeking a QA Analytical Specialist (QAAS) QA Lead to take ownership of quality assurance for analytical activities and stability studies. You will lead the QA oversight for analytical methods supporting clinical and commercial use, ensuring compliance with GMP guidelines, regulatory requirements, and Sobi’s high standards. This pivotal role involves approving product specifications, managing Quality Technical Agreements (QTAs) with Contract Laboratory Organizations (CLOs), and providing strategic QA support across departments and complex projects.

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.

Qualifications

You are an independent and proactive professional with a natural ability to take initiative and drive tasks forward. Your strong communication skills allow you to collaborate effectively across teams and with external stakeholders. A dedicated team player, you thrive in a collaborative environment and consistently align your work with Sobi’s CARE values.

• 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).

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