Senior QA Lead, Clinical Supply Chain & Compliance

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

Job summary

Undutchables is seeking a Senior Quality Assurance Associate – Clinical Supply Chain to ensure medicines used in clinical trials meet quality and regulatory standards. You will oversee QA processes for packaging, labeling, storage and distribution, collaborating with Production, Warehouse, Supply Chain, Quality and Regulatory Affairs to maintain compliance across the full product lifecycle.

In addition, you will review documentation, approve artwork, monitor storage conditions, investigate

Qualifications

• Experience in QA for clinical trial products.
• Familiarity with GMP/GDP standards.
• Ability to review batch documentation for release.
• Collaborative with cross-functional teams (Production, QA, Regulatory).

Responsibilities

• Review batch documentation to support release of investigational products.
• Review and approve clinical trial label artwork for regulatory compliance.
• Assess temperature deviations during transportation and storage.
• Investigate quality and compliance issues in manufacturing and distribution.
• Prepare monthly quality reports and monitor KPIs.
• Create and update SOPs and work instructions.
• Provide hands-on QA support during packaging and labeling activities.
• Perform QA checks to ensure GMP and GDP standards.
• Collaborate with departments to identify quality risks and improvements.

Skills

Quality Assurance

Regulatory compliance

GMP

GDP

Job description

Undutchables is seeking a Senior Quality Assurance Associate – Clinical Supply Chain to ensure medicines used in clinical trials meet quality and regulatory standards. You will oversee QA processes for packaging, labeling, storage and distribution, collaborating with Production, Warehouse, Supply Chain, Quality and Regulatory Affairs to maintain compliance across the full product lifecycle.

In addition, you will review documentation, approve artwork, monitor storage conditions, investigate