Specialist Quality Assurance - Qa Npd

Johnson & Johnson

Leiden, Netherlands
Base: 53,500.00 to 85,445.00 annually; bonus/equit...
Quality oversight to technology transfer
Gmp compliance throughout product introduction
Review and approve document changes
Provides QA support to the introduction, launch, and lifecycle transition of new products to the Leiden manufacturing site

Job Summary

  • Provides QA support to the introduction, launch, and lifecycle transition of new products to the Leiden manufacturing site.
  • Provides independent review and ensures that clear, pragmatic, and quality‑driven advice is given regarding the state of GMP compliance throughout product introduction, scale‑up, and lifecycle activities.
  • Acts as quality SME and supports preparation for, and participation during, inspections (e.g. FDA, EMA), including APR activities and inspection readiness, to ensure successful audits.

Matching Summary

Provides QA support to the introduction, launch, and lifecycle transition of new products to the Leiden manufacturing site.

Salary

Base: 53,500.00 to 85,445.00 annually; Bonus/Equity: Not specified; Benefits: 8% holiday allowance

Skills & Requirements

Must-have

  • Quality oversight to technology transfer
  • GMP compliance throughout product introduction
  • Review and approve document changes
  • Participates as Core Team Member in New Product Introduction projects
  • Assess and review Quality Investigations and non-conformances

Nice-to-have

  • Foster a strong quality and compliance culture
  • Customer-oriented attitude
  • Influences without formal authority

Key Requirements

  • Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education
  • BSc 6 years and for MSc 4 years of experience in a GMP regulated environment
  • Proficiency in English both in word and in writing
  • Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter