Senior QA Leader - Qualified Person (GMP)

Johnson & Johnson Co.; Sassenheim; On-site; EUR 88,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson is seeking a Qualified Person to provide QA oversight for commercial and clinical AT products at the Sassenheim site. You will review investigations, support CAPA, and ensure compliance with cGMP and regulatory requirements, working with Operations, QC and Engineering.

You will approve change controls, participate in risk assessments, and assist during inspections by Health Authorities. The role demands strong GMP knowledge, leadership, and the ability to drive quality

Qualifications

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
• Proficiency in English both in word and in writing.
• Proven knowledge of GMP/cGMP guidelines in Operations.
• Experience with QA systems: change control, deviation management, validation.

Responsibilities

• Provides QA oversight for production of Commercial and/or clinical AT products at the Sassenheim site.
• Reviews investigations, supports CAPA, and monitors Root Cause investigations.
• Escalates quality/compliance issues to site or global management and coordinates escalation meetings.
• Supports development of corrective and preventive actions and provides QA approval.
• Ensures non-conformance/CAPA programs are improved and aligns with cGMP and regulatory requirements.

Job description

Johnson & Johnson is seeking a Qualified Person to provide QA oversight for commercial and clinical AT products at the Sassenheim site. You will review investigations, support CAPA, and ensure compliance with cGMP and regulatory requirements, working with Operations, QC and Engineering.

You will approve change controls, participate in risk assessments, and assist during inspections by Health Authorities. The role demands strong GMP knowledge, leadership, and the ability to drive quality