Quality Engineer: CAPA, Change Control & GMP Lead

jj; Leiden; On-site; EUR 45,000 - 71,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a Quality Engineer in Leiden to ensure top-notch quality management systems and GMP compliance within the DSP CoE. You will lead investigations, CAPA records, and change controls from start to finish, driving timely resolutions.

The role requires an HBO degree with 3+ years in quality or GMP areas, and strong analytical, communication, and stakeholder-management skills in English (B2).

Qualifications

• Requires HBO degree with 3+ years in Quality, Manufacturing, or GMP-regulated industry.
• Experience leading or supporting quality investigations and change controls.
• Strong knowledge of GMP, CAPA, Change Control, quality systems, root cause analysis, and data analysis.

Responsibilities

• Apply quality expertise to support Operations objectives, ensuring GMP compliance.
• Lead non-conformance investigations, CAPA records, and Change Controls from initiation to completion.
• Review and maintain quality documents, procedures, and records for regulatory audits.
• Drive continuous improvement through risk mitigation, GEMBA walks, data analysis, and quality projects.
• Support audits and inspections, develop GMP training initiatives, and collaborate with stakeholders.

Skills

Quality systems

GMP & CAPA

Change Control

Root cause analysis

Data analysis

Risk management

Communication

Education

HBO degree

Tools

MS Office

Job description

Johnson & Johnson is seeking a Quality Engineer in Leiden to ensure top-notch quality management systems and GMP compliance within the DSP CoE. You will lead investigations, CAPA records, and change controls from start to finish, driving timely resolutions.

The role requires an HBO degree with 3+ years in quality or GMP areas, and strong analytical, communication, and stakeholder-management skills in English (B2).