Pharma QA Specialist: cGMP & CAPA Leadership

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

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson Innovative Medicine Biologics Leiden is seeking a Quality Assurance Specialist to ensure site and supply chain activities meet cGMP standards and regulatory expectations. You will work with colleagues to resolve quality challenges and drive improvements, requiring fluency in Dutch and English.

The role focuses on investigations, CAPA, change controls, and risk management to safeguard product quality and patient safety, with collaboration across the QA-OCP team.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

cGMP

Root cause analysis

CAPA

Regulatory readiness

Dutch & English

Communication

Education

Bachelor’s degree in bioscience/chemistry/pharmacy

Master’s degree in related field

Tools

LEAN tools

Job description

Johnson & Johnson Innovative Medicine Biologics Leiden is seeking a Quality Assurance Specialist to ensure site and supply chain activities meet cGMP standards and regulatory expectations. You will work with colleagues to resolve quality challenges and drive improvements, requiring fluency in Dutch and English.

The role focuses on investigations, CAPA, change controls, and risk management to safeguard product quality and patient safety, with collaboration across the QA-OCP team.