Head Of Product Quality Manufacturing And Testing

argenx

Onsite
10+ years qa experience in biopharmaceuticals
Gmp strategic authority for manufacturing
Experience with fda eu pmda regulations
The role involves setting the strategic direction for Manufacturing and Testing Product Quality to enable reliable and compliant product delivery

Job Summary

  • The role involves setting the strategic direction 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 across the product lifecycle.
  • The position requires extensive experience managing health authority inspections and governing quality standards for external partners.

Matching Summary

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

Skills & Requirements

Must-have

  • 10+ years QA experience in biopharmaceuticals
  • GMP strategic authority for manufacturing
  • Experience with FDA EU PMDA regulations
  • Management of third-party manufacturers
  • Leadership of high-performing quality teams

Nice-to-have

  • Strong collaborative leadership skills
  • Culture of continuous improvement
  • Excellent scientific writing skills
  • Ability to operate in dynamic environment
  • Data-driven decision-making capabilities

Key Requirements

  • 10+ years experience in quality assurance
  • Knowledge of analytical techniques
  • Experience with regulatory inspections (FDA, EMA, PMDA)
  • Solid scientific writing skills in English

Work Rights

Not specified

Tailored Resume

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