Head Of Product Quality Manufacturing And Testing

argenx

Gent, Belgium
Onsite
10+ years experience in quality assurance
Biopharmaceutical manufacturing operations knowledge
Gmp strategic authority for manufacturing
argenx is seeking a Head of Product Quality Manufacturing and Testing to lead strategic direction and ensure quality compliance within its expanding biopharmaceutical operations. The ideal candidate will have extensive experience in quality assurance, particularly in the biopharmaceutical sector, and possess strong leadership and stakeholder management skills

Job Summary

  • The role involves setting the strategic direction and vision for Manufacturing and Testing Product Quality to enable reliable, compliant, and efficient 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 possessing in-depth knowledge of FDA, EU, and PMDA regulations.

Matching Summary

Match Score: 85

argenx is seeking a Head of Product Quality Manufacturing and Testing to lead strategic direction and ensure quality compliance within its expanding biopharmaceutical operations. The ideal candidate will have extensive experience in quality assurance, particularly in the biopharmaceutical sector, and possess strong leadership and stakeholder management skills.

Skills & Requirements

Must-have

  • 10+ years experience in quality assurance
  • Biopharmaceutical manufacturing operations knowledge
  • GMP strategic authority for manufacturing
  • FDA EU PMDA regulations and ICH Guidelines
  • Experience managing health authority inspections
  • Third-party manufacturer oversight experience

Nice-to-have

  • Strong strategic and collaborative leadership skills
  • Culture of continuous improvement and innovation
  • Excellent relationship management with stakeholders
  • Ability to operate in dynamic fast-growing environment
  • Data-driven decision-making capabilities

Key Requirements

  • 10+ years in quality assurance role
  • Experience with biological manufacturing operations
  • Knowledge of analytical techniques
  • Experience with audits and regulatory inspections
  • Solid scientific writing skills in English

Work Rights

Not specified

Tailored Resume

Cover Letter