Head, Clinical Trial Qa

Seqirus

Americas, PA, United States
Clinical trial quality assurance
Gcp compliance expertise
Inspection management
The Head of Clinical Trial Quality Assurance role maintains and enhances the Global Clinical Trial Quality System supporting early to late-stage clinical development projects within R&D

Job Summary

  • The Head of Clinical Trial Quality Assurance role maintains and enhances the Global Clinical Trial Quality System supporting early to late-stage clinical development projects within R&D.
  • This position provides strategic direction and managerial oversight globally, including preparation for health authority inspections and third-party audits.
  • CSL Behring is a global biotherapeutics leader committed to innovation and inclusion, employing 32,000 people and serving patients in over 100 countries.

Matching Summary

The Head of Clinical Trial Quality Assurance role maintains and enhances the Global Clinical Trial Quality System supporting early to late-stage clinical development projects within R&D.

Skills & Requirements

Must-have

  • Clinical Trial Quality Assurance
  • GCP compliance expertise
  • Inspection management
  • Deviation and CAPA management
  • Risk and change management
  • Global quality governance
  • Cross-functional team leadership

Nice-to-have

  • Pharmacovigilance knowledge
  • Pre-clinical and GMP experience
  • Strategic thinking and problem solving
  • Mentoring and coaching skills
  • Strong communication and negotiation
  • Customer focus and influencing skills

Key Requirements

  • Undergraduate degree in Scientific discipline
  • 10+ years pharmaceutical Quality Assurance experience
  • Experience with Quality Management Systems
  • Inspection management experience preferred
  • Leadership in clinical regulations
  • Proficient in English
  • Work experience in global cross-functional teams

Work Rights

Not specified

Tailored Resume

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