Senior Quality Assurance Specialist

A leading biotechnology organization dedicated to serving patients worldwide. This company provides innovative medicines across a global network, focusing on maintaining a strong scientific foundation while fostering an entrepreneurial spirit. They promote fulfilling careers through challenging projects, professional development, and meaningful opportunities within a diverse and dynamic environment.

We are seeking a detail-oriented Senior Quality Assurance Specialist to oversee QA activities within the clinical supply chain. The role involves ensuring compliance with GMP and GDP standards for clinical trial products, supporting manufacturing and distribution processes, and maintaining high-quality standards across all supply chain operations.

• Provide QA oversight for the clinical supply chain, including receipt, storage, and distribution of clinical trial products.
• Review and support batch certification processes to ensure compliance with EU and international regulations.
• Approve clinical label artwork and review deviations, ensuring procedural adherence.
• Assess and manage temperature excursions during transport and at clinical sites.
• Collaborate with stakeholders such as Global Clinical Supply Chain, Warehouse, Production, Quality, Clinical Research, and Regulatory Affairs to resolve compliance issues.
• Develop, review, and update SOPs and work instructions to align with corporate and regulatory standards.
• Prepare and analyze monthly quality metrics.
• Support on-site clinical packaging and labeling operations - including batch record review and issue resolution.
• Identify quality issues and work cross-functionally to implement corrective actions.

• Master's degree in Life Sciences or a related field.
• At least 3 years of QA or manufacturing experience within the pharmaceutical or medical device industry.
• Knowledge of GMP, GDP, and GCP regulations.
• Fluent in English, with strong communication skills.