Senior Quality Assurance Specialist

Sire Search; Breda; On-site; EUR 65,000 - 90,000; Full time

Job summary

Sire Search in the Netherlands is seeking a detail-oriented Senior Quality Assurance Specialist to oversee QA activities within the clinical supply chain, ensuring GMP and GDP compliance for clinical trial products. You will support manufacturing and distribution processes, review batch certifications, approve clinical label artwork, and manage temperature excursions during transport.

Collaborating with Global Clinical Supply Chain, Warehouse, Production, Quality, Clinical Research and

Qualifications

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

Responsibilities

• 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 across 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.

Skills

Quality Assurance

Regulatory Compliance

Documentation

Audit Support

Education

Master's degree in Life Sciences

Tools

LIMS

ERP systems

Job description

Company

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.

Job Description

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.

Responsibilities

• 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.

Requirements

• 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.