Sr. QA Associate – Clinical Supply Chain & Manufacturing | Pharmaceutical Industry

We are seeking a Sr. Associate QA Clinical Supply Chain to provide quality oversight in the supply chain of clinical trial products.In this role, you will ensure compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards while supporting clinical production activities. You will collaborate with multiple stakeholders to ensure the seamless distribution of investigational medicinal products to clinical sites and depots.
Key Responsibilities:

• Review batch documentation for QP certification and compliance.
• Approve clinical label artwork and assess temperature excursions.
• Ensure compliance with GMP, GDP, and regulatory standards.
• Support issue resolution in manufacturing and distribution.
• Maintain SOPs, review deviations, and prepare quality metrics.
• Provide QA support for clinical packaging and labeling operations.

Requirements:

• Master’s degree in Life Sciences or a related field.
• 3+ years of Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry.
• Knowledge of GMP, GDP, and/or Good Clinical Practice (GCP).
• Experience in batch record review, investigations, and analytical testing.
• Fluency in English.

Salary Benefits:

• A dynamic and international work environment with career development opportunities.
• Hybrid position: work on-site in Breda two to three times per week.
• Competitive salary package.
• Travel expense reimbursement, dependent on distance.
• The contract will be through Undutchables.

Our client is an international market leader in the pharmaceutical industry – focused on transforming science and biotechnology into therapies that have the power to restore health or save lives. The patients are the main priority at all times. This USA founded organization holds a large site in Breda, where produced medicines are labeled, stored and shipped worldwide, to more than 75 countries. The staff in Breda works on supply chain processes, engineering, clinical research, marketing and sales on a daily basis. The company culture is dynamic and fast paced, with a strong international character.