Quality Assurance Specialist

We are searching for the best talent for the Quality Assurance Specialist to be based in Leiden.

Join our QA Operational Commercial Products (QA‑OCP) team at Johnson & Johnson Innovative Medicine Biologics Leiden to help ensure site and supply chain activities meet cGMP standards, support regulatory readiness, and protect product quality and patient safety. You’ll work closely with colleagues across the site to solve quality challenges and drive improvements—fluency in Dutch and English is required!

You will be responsible for:

• Provide timely, practical cGMP and quality advice during routine and non-routine operations to maintain compliance and keep site activities on track.
• Lead end-to-end site investigations and drive CAPA implementation to prevent recurrence and improve site performance.
• Prepare for and support regulatory inspections (e.g., FDA, EMA) to maintain inspection readiness and support successful audit outcomes.
• Review, assess, and approve change controls for commercial production and quality control testing to ensure compliant, well-documented changes.
• Evaluate and approve study and validation protocols and reports so studies run in a controlled, systematic, and compliant way.
• Collaborate with site colleagues in quality risk management and root cause analysis to identify risks and deliver continuous improvement.

Qualifications/Requirements:

• Bachelor’s degree in bioscience, chemistry, pharmacy, or a related field with 4–6 years’ relevant experience, OR a Master’s degree in a related field with 2–4 years’ relevant experience.
• Preferable experience working in Quality Assurance within the pharmaceutical industry or a related field.
• Demonstrated experience leading quality investigations, conducting root cause analysis, and managing CAPAs.
• Up-to-date knowledge of cGMP and applicable regulatory expectations.
• Strong communication, collaboration, and advisory skills in both Dutch and English, verbal and written
• Familiarity with Process Excellence (PE), LEAN tools, concepts, or similar process improvement methods is preferred.

Hybrid work