This role provides leadership and management for clinical compliance staff working to ensure that clinical study teams are following GCP practices
Job Summary
This role provides leadership and management for clinical compliance staff working to ensure that clinical study teams are following GCP practices.
The position drives Quality by Design and risk-based approaches to study design and conduct in coordination with partners responsible for implementing and overseeing clinical trials.
You will partner with Clinical Development Operations and Global Quality Assurance as needed during audits, regulatory inspections and other study assessment activities.
Matching Summary
This role provides leadership and management for clinical compliance staff working to ensure that clinical study teams are following GCP practices.
Skills & Requirements
Must-have
GCP practices
Quality by Design
risk-based approaches
ICH GCP Guidelines
CAPA Management
Nice-to-have
agile team
dynamic biotech ecosystems
meaningful difference worldwide
Key Requirements
BSc/MSc/Diploma in scientific/medical/pharmaceutical discipline
10+ years of professional work experience
3+ years of line management experience
Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directive