Qualified Person

Johnson & Johnson

Sassenheim, Netherlands
Base: 88.400 eur - 119.600 eur; bonus/equity: not ...
Quality oversight of at product manufacturing
Gmp compliance and regulatory adherence
Quality investigation and root cause analysis
The Qualified Person provides QA support to the commercial and/or clinical Advanced Therapy products manufactured at the Sassenheim manufacturing site and ensures GMP compliance

Job Summary

  • The Qualified Person provides QA support to the commercial and/or clinical Advanced Therapy products manufactured at the Sassenheim manufacturing site and ensures GMP compliance.
  • This role involves leading quality investigations, approving product releases, supporting corrective and preventative actions, and participating in inspections and risk assessments.
  • Johnson & Johnson offers an inclusive work environment that respects diversity and dignity, empowering employees to innovate and impact health for humanity.

Matching Summary

The Qualified Person provides QA support to the commercial and/or clinical Advanced Therapy products manufactured at the Sassenheim manufacturing site and ensures GMP compliance.

Salary

Base: 88.400 EUR - 119.600 EUR; Bonus/Equity: Not specified; Benefits: Includes 8% holiday allowance

Skills & Requirements

Must-have

  • Quality oversight of AT product manufacturing
  • GMP compliance and regulatory adherence
  • Quality investigation and root cause analysis
  • Change control and document approval
  • Quality Risk Management participation
  • Quality training and coaching
  • Inspection readiness and audit support

Nice-to-have

  • Cross-departmental collaboration
  • Inclusive work environment
  • Problem solving and troubleshooting
  • Leadership and team management
  • Process excellence methodologies

Key Requirements

  • Bachelor’s degree in Biochemistry, Biology, Pharmaceutical or relevant field
  • Proven knowledge of biotechnological/lentiviral/pharmaceutical industry
  • Proficiency in English written and spoken
  • Deep understanding of Global Regulatory guidelines (cGMP/ICH/FDA/EMA)
  • Experience with QA systems including change control and deviation management
  • Ability to make independent quality decisions in complex environments

Work Rights

Not specified

Tailored Resume

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