Senior GMP Quality Engineer

SIRE LIFE SCIENCES; Leiden; On-site; EUR 60,000 - 80,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a Senior Quality Engineer in Leiden, Netherlands, to lead quality investigations within a pharmaceutical manufacturing setting. The role focuses on managing non-conformance issues and ensuring compliance with regulatory standards while driving operational excellence.

The ideal candidate will have 7–10 years of relevant experience in Quality Engineering, strong problem-solving skills, and a proven track record in CAPA and Change Control processes. Excellent stakeholder management and communication abilities are essential for this position.

Qualifications

• 7–10 years of experience in Quality Engineering or pharmaceutical manufacturing.
• Strong experience with non-conformance investigations and CAPA activities.
• Proficiency in English (B2+) and data analysis.

Responsibilities

• Lead and manage quality investigations.
• Oversee CAPA and Change Control processes.
• Review and maintain quality documentation.
• Conduct risk assessments and implement mitigation plans.
• Coordinate cross-functional teams and communicate outcomes.

Skills

Root cause analysis

Stakeholder management

Continuous improvement

Problem-solving

GMP regulatory compliance

Education

Relevant Bachelor's (HBO) degree

Tools

MS Office

Quality systems

Job description

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+).