Quality Investigation Lead (CAPA & GMP)

Johnson & Johnson; Leiden; On-site; EUR 55,000 - 83,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Engineer (Investigation Owner) to lead and manage investigations related to manufacturing processes and products. You will identify root causes, coordinate CAPA actions, and ensure regulatory compliance while collaborating with cross-functional teams.

The role requires a HBO degree with 3–5 years of pharma experience, English B2, and strong data analysis and documentation skills. The contract is 12 months and the environment is highly professional.

Qualifications

• HBO degree with 3–5 years in quality investigations or similar roles in pharma.
• English level B2 required and strong problem solving skills.
• Experience leading quality records, CAPA and change controls.

Responsibilities

• Lead and manage quality investigations across manufacturing processes and systems.
• Coordinate CAPA records and change controls from initiation to completion.
• Review process documentation and ensure GMP compliance on the production floor.
• Escalate risks and drive continuous quality improvements with stakeholders.
• Perform GEMBA walks to observe and document adherence to GMP standards.

Skills

Quality investigations

CAPA handling

Root cause analysis

GEMBA walks

Documentation

Education

HBO degree in quality/engineering

Tools

MS Office

Data analysis tools

Job description

Johnson & Johnson is seeking a Quality Engineer (Investigation Owner) to lead and manage investigations related to manufacturing processes and products. You will identify root causes, coordinate CAPA actions, and ensure regulatory compliance while collaborating with cross-functional teams.

The role requires a HBO degree with 3–5 years of pharma experience, English B2, and strong data analysis and documentation skills. The contract is 12 months and the environment is highly professional.