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Senior QA Specialist Lead
11 hours ago
Transforming Lives with Quality
Sobi Group is dedicated to delivering innovative therapies that change lives. We are seeking a seasoned professional to lead our quality assurance efforts in analytical activities and stability studies.
About the Role
We are looking for a talented individual with strong communication skills, who can collaborate effectively across teams and with external stakeholders. As a Senior QA Specialist Lead, you will oversee quality assurance for analytical methods supporting clinical and commercial use, ensuring compliance with GMP guidelines and regulatory requirements.
Key Responsibilities
- Ensure correct implementation of GMP guidelines in QA Analytics processes.
- Approve product specifications, manage Quality Technical Agreements (QTAs) with Contract Laboratory Organizations (CLOs), and provide strategic QA support.
- 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).
Culture at Sobi Group
We value work-life balance and emphasize collaboration and teamwork. Our mission and culture drive us to come to work every day, and we believe in harnessing the unique talents of individuals to create innovative therapies. If you are passionate about making a difference in the world of rare disease patients, we encourage you to apply.
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