Senior Quality Engineer - Lead GMP & Continuous Improvement

Get 360Pharma; Leiden; On-site; EUR 65,000 - 95,000; Full time

Job summary

Get 360Pharma in Leiden, The Netherlands, is seeking a Senior Quality Engineer to reinforce our Operations quality team. The role focuses on implementing quality objectives, handling nonconformances, and updating procedures to reflect regulatory changes.

You will lead risk mitigation, drive continuous improvement, perform GEMBA walks for GMP compliance, and mentor teammates while collaborating with cross-functional stakeholders in a fast-paced pharma environment.

Qualifications

• Dutch language level A2 and English level B2 required.
• Bachelor or HBO in relevant field with required years of experience.
• Proficient in MS Office and data analysis.
• High accuracy and quality-focused attitude.
• Analytical thinking and root-cause analysis ability.
• Ability to work independently and in a team.
• Experience leading change controls or quality investigations.

Responsibilities

• Implement Operations quality objectives and perform nonconformance investigations.
• Update documentation per regulatory requirements and audits.
• Ensure compliant documentation and timely quality records.
• Initiate risk mitigations and drive continuous quality improvement.
• Support escalation processes for safety, product quality, and regulatory risks.
• Coach junior staff on risk mitigations and continuous quality projects.
• Lead cross-functional Operations quality improvements with stakeholders.
• Perform GEMBA walks to ensure GMP compliance and drive improvements.
• Develop training on cGMP processes and act as SME on non-conformances and Change Controls.
• Analyze data on recurring non-conformances and recommend corrective actions.

Skills

Analytical Reasoning

Coaching

Customer Centricity

Data Savvy

Document Management

Analytical Thinking

Team Leadership

Education

University degree or HBO with 5 years

Tools

MS Office

Data Analysis

Job description

Get 360Pharma in Leiden, The Netherlands, is seeking a Senior Quality Engineer to reinforce our Operations quality team. The role focuses on implementing quality objectives, handling nonconformances, and updating procedures to reflect regulatory changes.

You will lead risk mitigation, drive continuous improvement, perform GEMBA walks for GMP compliance, and mentor teammates while collaborating with cross-functional stakeholders in a fast-paced pharma environment.