Qualified Person — GMP Quality Lead

Johnson & Johnson Innovation; Netherlands; On-site; Confidential; Full time

Job summary

Johnson & Johnson is seeking a Qualified Person to provide QA oversight for commercial and clinical Advanced Therapy products at the Sassenheim site. You will ensure cGMP compliance and lead QA reviews, CAPA, and investigations to protect product quality and patient safety.

You will collaborate with Operations, QC, MSAT, Engineering and Regulatory teams, participate in inspections, and coach QA staff while driving continuous improvement in quality systems and change controls.

Qualifications

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
• English proficiency in word and writing.
• Experience in GMP, QA and regulatory environments.

Responsibilities

• Provide QA oversight for the production of commercial and clinical AT products; ensure GMP compliance.
• Review investigations and CAPAs; determine product disposition and escalate incidents as needed.
• Support regulatory readiness and inspections; train site staff in QA practices.

Skills

Quality mindset

Regulatory knowledge

Leadership

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree

Tools

Process Excellence

Kepner-Tregoe

Quality Management System (QMS)

Job description

Johnson & Johnson is seeking a Qualified Person to provide QA oversight for commercial and clinical Advanced Therapy products at the Sassenheim site. You will ensure cGMP compliance and lead QA reviews, CAPA, and investigations to protect product quality and patient safety.

You will collaborate with Operations, QC, MSAT, Engineering and Regulatory teams, participate in inspections, and coach QA staff while driving continuous improvement in quality systems and change controls.