You are responsible for leading a global clinical quality management and inspection readiness team
Job Summary
You are responsible for leading a global clinical quality management and inspection readiness team.
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.
Matching Summary
You are responsible for leading a global clinical quality management and inspection readiness team.
Skills & Requirements
Must-have
Global clinical quality management
Inspection readiness team leadership
GCP practices adherence
Quality by Design implementation
Risk-based approaches to study design
ICH GCP Guidelines knowledge
Nice-to-have
Agile team environment
Collaboration with partners
Patient impact focus
Dynamic biotech ecosystems
Key Requirements
10+ years professional work experience
Degree in scientific/medical/pharmaceutical discipline
3+ years line management experience
Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directive