About this role
SIRE Life Sciences Logo Senior GMP Quality Engineer, Leiden, Zuid-Holland Location: Leiden, Zuid-Holland | Sector: Pharmaceuticals | Start Date: 6/4/2026 | Job ref: 58148 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,...