Sr. Associate QA (GMP)

Senior Associate QA - Amgen Breda

Join a Leading Biopharmaceutical Organisation

We are seeking a detail-oriented Senior Associate Quality Assurance (QA) to support quality operations within a highly regulated pharmaceutical manufacturing environment in Breda, Netherlands. This is an excellent opportunity for a quality professional with GMP experience who enjoys working with cross-functional teams, ensuring compliance, and maintaining high-quality standards for medicinal products.

This position offers the opportunity to contribute to critical QA processes, including SAP Master Data review, artwork approval, SOP management, and continuous quality improvement initiatives.

Contract Duration: 7 November 2026 – 6 May 2027 - strong possibility of an extension

Location: Breda, Netherlands

Hourly Rate: €25.50 - €26.84

Language Requirement: Fluent in Dutch and English

Key Responsibilities

Quality Assurance & Compliance

• Perform QA review and approval of SAP Master Data activities, including critical value verification and Bills of Materials.
• Review and approve artwork for medicinal products.
• Ensure compliance with GMP and applicable regulatory requirements.
• Monitor and maintain QA systems and quality processes.

Documentation & Quality Systems

• Author and maintain operational SOPs and Work Instructions.
• Conduct QA review and approval of SOPs and related documentation.
• Support data integrity initiatives and investigate quality-related issues.
• Assist with investigations, root cause analysis, and corrective actions as required.

Performance & Continuous Improvement

• Prepare weekly and monthly quality metrics and reports.
• Maintain departmental performance boards and KPI tracking.
• Participate in QA projects and process improvement initiatives.
• Build effective working relationships with Global Artwork Centre, Master Data teams, Regulatory Affairs, Supply Chain teams, SMEs, and QA leadership.

What We're Looking For

Required Qualifications

• MBO or Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, or a related field.
• Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience.
• Knowledge of GMP, GDP and/or GCP regulations.
• Experience working within a regulated pharmaceutical or medical device environment.
• Strong attention to detail and high level of accuracy.
• Excellent communication skills in English.
• Ability to manage priorities and perform effectively under pressure.

Preferred Qualifications

• Dutch language proficiency.
• Experience reviewing SAP Master Data.
• Artwork approval experience within the pharmaceutical industry.
• Experience with SOP writing and document management processes.

Why Apply?

• Gain experience within a globally recognised biopharmaceutical organisation.
• Work in a highly collaborative and quality-focused environment.
• Contribute directly to patient safety and product quality.
• Develop expertise in pharmaceutical compliance, artwork management, and master data governance.