Offer summary
Qualifications:
BA/BS degree required, Expert knowledge of FDA, EU, ICH GCP guidelines, Minimum 7 years in GCP-related Quality Assurance, Understanding of international GCP requirements, Excellent communication skills in English.
Key responsabilities:
- Manage inspection readiness for clinical study teams
- Supervise FDA, EMA, and other inspections
- Develop and implement inspection management tools
- Lead post-inspection activities and corrective actions
- Mentor junior staff and establish development plans