Quality Engineer — GMP, CAPA & Change Control

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 45,000 - 71,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leiden is seeking a Quality Engineer within the DSP CoE to apply quality requirements to support Operations objectives, including nonconformance investigations, CAPA records, and Change Controls.

You will own records, ensure timely timelines, and drive sustainable resolutions while collaborating with stakeholders and maintaining GMP compliance.

Qualifications

• HBO degree with 3+ years of quality, manufacturing, or GMP-regulated experience.
• Strong knowledge of GMP, CAPA, Change Control, quality systems, risk management, and data analysis.
• Excellent communication, stakeholder management, analytical thinking, prioritization, and English (B2).

Responsibilities

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

Skills

Quality engineering

CAPA

Change control

GMP

Data analysis

Root cause analysis

Risk management

MS Office / business apps

Education

HBO degree in Quality/Engineering

Tools

MS Office

Quality systems documentation

Job description

Johnson & Johnson Innovative Medicine in Leiden is seeking a Quality Engineer within the DSP CoE to apply quality requirements to support Operations objectives, including nonconformance investigations, CAPA records, and Change Controls.

You will own records, ensure timely timelines, and drive sustainable resolutions while collaborating with stakeholders and maintaining GMP compliance.