QA Operational Readiness Officer

Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.

Your work is crucial to the success of these projects.

Responsibilities

• As a QA Operational Readiness Officer, you ensure GMP compliance and overall quality readiness for the successful startup of the new production facility.
• You provide real-time quality support to project teams and escalate critical quality issues when needed. 
• You review quality events, root cause analyses, CAPAs, and effectiveness checks, ensuring timely completion. 
• You assess change controls for quality impact and ensure correct documentation and approval. 
• You perform GEMBA walks and maintain quality management system documentation. 
• You conduct readiness assessments and gap analyses for quality systems and processes. 
• You coordinate cross-functional readiness activities with manufacturing, supply chain, regulatory, and engineering teams. 
• You follow up on qualification activities (DQ, IQ, OQ, PQ) and oversee quality-critical facility systems. 
• You support design qualification, regulatory submissions, quality documentation, PAIs, and inspections. 
• You perform quality risk assessments, define mitigation strategies, and monitor risk indicators to prevent quality issues. 

Requirements

• Bachelor or Master in Life Sciences, Engineering, Quality Management, or related field. 
• 4-6 years of experience in pharmaceutical/biotech Quality Assurance. 
• Strong knowledge of GMP and quality systems. 
• Skilled in risk and change management. 
• Understanding of pharma manufacturing processes. 
• Strong communication and stakeholder management. 
• Able to work cross-functionally and manage multiple priorities. 
• Analytical, detail-oriented, and problem-solving mindset. 
• Fluent in Dutch and English. 

At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.

Together we make sure you get the most out of your career.