Senior QA Specialist - GMP Compliance & Investigations

Johnson & Johnson Co.; Amsterdam; On-site; EUR 55,000 - 87,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands, seeks an Experienced QA Specialist to strengthen GMP compliance, product quality, and operational excellence in a pharmaceutical manufacturing setting.

You will work with Operations, Quality Control, and Manufacturing to provide quality guidance, investigations, risk management, and inspection readiness while ensuring compliance with company standards and regulatory requirements.

Qualifications

• Bachelor's degree or Master's with required years of experience in pharmaceutical QA.
• Experience in GMP and quality investigations is preferred.
• Fluent in Dutch and English, both written and spoken.

Responsibilities

• Providing timely quality guidance on cGMP topics.
• Leading site investigations and CAPA implementation.
• Supporting regulatory inspection preparations (FDA/EMA).
• Reviewing deviation-related change controls.
• Collaborating with site colleagues to ensure compliance.
• Reviewing study protocols and reports including validation/stability.
• Participating in Quality Risk Management and continuous improvement.

Skills

GMP regulations

Quality Assurance

Quality investigations

Root cause analysis

Process Excellence / Lean

Analytical & problem solving

Cross-functional collaboration

AI awareness

Education

Bachelor's degree in Bioscience/ Chemistry/ Pharmacy

Master's degree in Bioscience/ Chemistry/ Pharmacy

Job description

Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands, seeks an Experienced QA Specialist to strengthen GMP compliance, product quality, and operational excellence in a pharmaceutical manufacturing setting.

You will work with Operations, Quality Control, and Manufacturing to provide quality guidance, investigations, risk management, and inspection readiness while ensuring compliance with company standards and regulatory requirements.