Qualified Person

Johnson & Johnson MedTech

Sassenheim, Netherlands
Base: 88,400 eur - 119,600 eur; bonus/equity: not ...
Quality oversight of at products manufacturing
Gmp compliance and regulatory adherence
Quality investigations and root cause analysis
The Qualified Person provides QA support to the commercial and 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 clinical Advanced Therapy products manufactured at the Sassenheim manufacturing site and ensures GMP compliance.
  • This role involves leading quality investigations, managing risk assessments, and supporting regulatory inspections to maintain high standards of product safety and efficacy.
  • Johnson & Johnson offers an inclusive work environment that respects diversity and fosters innovation to profoundly impact health for humanity.

Matching Summary

The Qualified Person provides QA support to the commercial and 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: 8% holiday allowance

Skills & Requirements

Must-have

  • Quality oversight of AT products manufacturing
  • GMP compliance and regulatory adherence
  • Quality investigations and root cause analysis
  • Change control and deviation management
  • Quality Risk Management participation
  • Quality systems and CAPA management
  • Inspection readiness and audit support

Nice-to-have

  • Cross-functional collaboration
  • Coaching and developing QA specialists
  • Inclusive leadership and team management
  • Problem solving and troubleshooting
  • Process excellence methodologies
  • Fact-based decision making
  • Effective communication and feedback

Key Requirements

  • Bachelor’s degree in Biochemistry, Biology or Pharmaceutical field
  • Proven knowledge of biotechnological/lentiviral/pharmaceutical industry
  • Proficiency in English oral and written
  • Deep understanding of global regulatory guidelines (cGMP/ICH/FDA/EMA)
  • Experience with QA systems and manufacturing processes
  • Ability to make independent quality decisions and escalate issues
  • Experience in process excellence methods recommended

Work Rights

Not specified

Tailored Resume

Cover Letter