QA Specialist, cGMP & Regulatory Readiness

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 Assurance Specialist to join the QA-OCP team. You will ensure site activities meet cGMP standards, support regulatory inspections, and drive improvements with colleagues across the site.

The role requires Dutch and English fluency, a bioscience-related degree with 4–6 years (or a related master's with 2–4 years), and strong investigative and CAPA skills.

Qualifications

• Bachelor’s degree in bioscience, chemistry, pharmacy, or a related field with 4–6 years’ relevant experience.
• Master’s degree in a related field with 2–4 years’ relevant experience.
• Preferable experience in Quality Assurance within the pharmaceutical industry.
• Experience leading quality investigations, root cause analysis, and CAPAs.
• Up-to-date knowledge of cGMP and regulatory expectations.
• Strong communication in Dutch and English, both verbal and written.

Responsibilities

• Provide timely, practical cGMP and quality advice to maintain compliance and keep site activities on track.
• Lead end-to-end site investigations and drive CAPA implementation to improve site performance.
• Prepare for and support regulatory inspections to maintain readiness and audit outcomes.
• Review and approve change controls for commercial production and quality control testing.
• Evaluate and approve study and validation protocols and reports to ensure controlled, compliant studies.
• Collaborate with quality colleagues on risk management and continuous improvement.

Skills

Quality Assurance

CAPA

Root cause analysis

cGMP

Regulatory knowledge

Dutch & English

Education

Bachelor’s degree in bioscience, chemistry, pharmacy, or related

Master’s degree in related field

Job description

Johnson & Johnson Innovative Medicine in Leiden is seeking a Quality Assurance Specialist to join the QA-OCP team. You will ensure site activities meet cGMP standards, support regulatory inspections, and drive improvements with colleagues across the site.

The role requires Dutch and English fluency, a bioscience-related degree with 4–6 years (or a related master's with 2–4 years), and strong investigative and CAPA skills.