The job is in our King of Prussia, PA or Maidenhead UK Office
Job Summary
The job is in our King of Prussia, PA or Maidenhead UK Office.
You are responsible for leading a global clinical quality management and inspection readiness team.
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
The job is in our King of Prussia, PA or Maidenhead UK Office.
Skills & Requirements
Must-have
GCP practices
Quality by Design
risk-based approaches
Quality Management System (QMS)
ICH GCP Guidelines
CAPA Management
Nice-to-have
collaboration
agile team
dynamic biotech ecosystems
patient impact
Key Requirements
Degree (BSc/MSc/Diploma) in scientific/medical/pharmaceutical discipline
10+ years of professional work experience
Extensive understanding of clinical research and drug development lifecycle
Experience in Compliance
3+ years of line management experience
Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directive