Head Of Product Quality Manufacturing And Testing

argenx

Onsite
10+ years quality assurance experience
Biopharmaceutical manufacturing operations knowledge
Gmp regulatory compliance expertise
The role involves setting the strategic direction and vision for Manufacturing and Testing Product Quality to enable reliable and compliant product delivery

Job Summary

  • The role involves setting the strategic direction and vision for Manufacturing and Testing Product Quality to enable reliable and compliant product delivery.
  • Candidates must serve as the GMP strategic authority, providing expert guidance to ensure sustained compliance and inspection readiness across the product lifecycle.
  • The position requires extensive experience managing health authority inspections and governing quality standards for third-party manufacturers and testing partners.

Matching Summary

The role involves setting the strategic direction and vision for Manufacturing and Testing Product Quality to enable reliable and compliant product delivery.

Skills & Requirements

Must-have

  • 10+ years quality assurance experience
  • Biopharmaceutical manufacturing operations knowledge
  • GMP regulatory compliance expertise
  • FDA EU PMDA inspection management
  • Third-party vendor oversight

Nice-to-have

  • Strong strategic leadership skills
  • Excellent stakeholder relationship management
  • Culture of continuous improvement
  • Data-driven decision making
  • Innovation in quality systems

Key Requirements

  • 10+ years in quality assurance
  • Experience with biological manufacturing
  • Knowledge of analytical techniques
  • Auditing and inspection preparation experience
  • FDA, EMA, PMDA regulatory knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter