Head Of Product Quality Manufacturing And Testing

argenx

Gent, Belgium
Onsite
10+ years quality assurance experience in biopharmaceuticals
Expert knowledge of fda, eu, and pmda regulations
Experience managing health authority inspections
argenx is seeking a Head of Product Quality Manufacturing and Testing to lead the strategic direction of their product quality initiatives. The role emphasizes collaboration, compliance, and the development of high-performing teams within a fast-growing biotech environment focused on innovative treatments for autoimmune diseases

Job Summary

  • This role sets the strategic vision for Manufacturing and Testing Product Quality to ensure reliable and compliant delivery of medicines for autoimmune patients.
  • The successful candidate will serve as the GMP strategic authority, governing quality standards for both internal operations and external manufacturing partners.
  • Argenx is building a science-based culture that values continuous improvement, innovation, and the development of high-performing global teams.

Matching Summary

Match Score: 85

argenx is seeking a Head of Product Quality Manufacturing and Testing to lead the strategic direction of their product quality initiatives. The role emphasizes collaboration, compliance, and the development of high-performing teams within a fast-growing biotech environment focused on innovative treatments for autoimmune diseases.

Skills & Requirements

Must-have

  • 10+ years quality assurance experience in biopharmaceuticals
  • Expert knowledge of FDA, EU, and PMDA regulations
  • Experience managing health authority inspections
  • Strategic leadership of manufacturing and testing quality teams
  • GMP strategy governance for third-party partners

Nice-to-have

  • Strong collaborative leadership and coaching skills
  • Ability to operate in a dynamic fast-paced environment
  • Excellent scientific writing and reporting capabilities
  • Proven track record in innovation and quality excellence

Key Requirements

  • 10+ years experience in quality assurance within biopharmaceuticals
  • Extensive experience with biological manufacturing operations
  • In-depth knowledge of analytical techniques and audit preparation
  • Demonstrated success preparing for FDA, EMA, and PMDA inspections

Work Rights

Not specified

Tailored Resume

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