Senior GMP Quality Engineer, Leiden, Zuid-Holland

The Company
Our client is a global healthcare and life sciences organization with a strong presence in the Netherlands, focused on developing innovative therapies and vaccines to address major global health challenges. The company operates in a highly regulated, technology-driven environment and promotes a collaborative culture centered on innovation, quality, and continuous improvement.

About the Role:
This role is focused on leading quality investigations within a pharmaceutical manufacturing environment, ensuring product quality, compliance, and operational excellence. The Senior Quality Engineer manages non-conformance investigations, CAPA activities, and change controls while identifying root causes and implementing corrective actions. The position collaborates closely with cross-functional teams to maintain regulatory compliance, improve processes, and ensure timely closure of quality records.

Responsibilities:
- Lead and manage quality investigations, including non-conformances, root cause analysis, and resolution of quality issues. 
- Oversee CAPA and Change Control processes to ensure timely implementation of corrective and preventive actions. 
- Review and maintain quality documentation, ensuring compliance with GMP, regulatory requirements, and internal standards. 
- Conduct risk assessments, implement mitigation plans, and drive continuous quality improvement initiatives. 
- Coordinate cross-functional teams, monitor investigation progress, and communicate risks, findings, and outcomes to stakeholders and management.

Requirements:
- Relevant Bachelor's (HBO) degree with 7–10 years of experience in Quality Engineering, investigations, or pharmaceutical manufacturing. 
- Strong experience managing non-conformance investigations, CAPA activities, and Change Control processes within a GMP-regulated environment. 
- Proven expertise in root cause analysis, risk assessment, problem-solving, and continuous improvement methodologies. 
- Excellent stakeholder management, communication, and cross-functional team coordination skills with the ability to manage multiple priorities. 
- Proficiency in MS Office, data analysis, and quality systems, combined with strong organizational skills and English language proficiency (B2+).

Other Information:
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