Provide expert support for clinical trial quality, ensure compliance with ICH-GCP and global regulatory expectations, and act as a key partner to internal teams and CROs
Job Summary
Provide expert support for clinical trial quality, ensure compliance with ICH-GCP and global regulatory expectations, and act as a key partner to internal teams and CROs.
Lead the preparation, coordination, and follow‑up activities related to health authority inspections and conduct a variety of audits.
Contribute to the development and optimization of quality processes, tools, and clinical systems to support continuous improvement.
Matching Summary
Provide expert support for clinical trial quality, ensure compliance with ICH-GCP and global regulatory expectations, and act as a key partner to internal teams and CROs.
Skills & Requirements
Must-have
ICH-GCP compliance
clinical trial quality oversight
health authority inspections
GCP training delivery
clinical electronic systems experience
Nice-to-have
pragmatic solutions identification
risk measurement and management
negotiation and influencing capabilities
independent and collaborative work
Key Requirements
Master's degree in a relevant scientific discipline
Minimum 6 years of industry or health authority experience
≥4 years in GCP Quality Assurance
Strong experience in Clinical Research & Development