Senior Project Quality Assurance Lead - Europe - Remote
Worldwide Clinical Trials
7+ years relevant gcp experience
Bachelor's degree in science or related field
Knowledge of ich guidelines and fda regulations
The role involves leading QA activities across multiple complex and global studies while ensuring compliance with study protocols and regulations
Job Summary
The role involves leading QA activities across multiple complex and global studies while ensuring compliance with study protocols and regulations.
Candidates must act as a GCP Subject Matter Expert, providing consultancy to project teams and managing quality issues through root cause analysis.
Worldwide Clinical Trials is a global team of over 3,500 experts committed to improving lives through pioneering approaches and high-quality standards.
Matching Summary
The role involves leading QA activities across multiple complex and global studies while ensuring compliance with study protocols and regulations.
Skills & Requirements
Must-have
7+ years relevant GCP experience
Bachelor's degree in science or related field
Knowledge of ICH Guidelines and FDA regulations
Experience with Quality Management Systems
Root cause analysis and CAPA plan development
Nice-to-have
M.S. in scientific or allied health field
GxP knowledge (GLP, GMP, GPVP, GPP)
CRO or pharmaceutical company setting experience
Strong influencing and negotiation skills
Willingness to travel up to 15%
Key Requirements
7+ years GCP experience OR 5+ years with M.S.
Bachelor's degree in biological, physical, health, pharmacy, or related science
Excellent working knowledge of European Directives and UK Statutory Instruments
Ability to manage projects of significant scope and complexity