The role serves as an inspection lead responsible for ensuring research and development activities comply with applicable global regulatory requirements and guidelines
Job Summary
The role serves as an inspection lead responsible for ensuring research and development activities comply with applicable global regulatory requirements and guidelines.
Candidates will manage end-to-end inspection readiness activities including the development of storyboards, proactive risk mitigation, and leadership of mock and actual Health Authority inspections.
BeOne is seeking highly motivated professionals who share a passionate interest in fighting cancer and are committed to driving excellence in clinical trial operations.
Matching Summary
The role serves as an inspection lead responsible for ensuring research and development activities comply with applicable global regulatory requirements and guidelines.
Salary
Base: 141,800.00 CHF - 177,300.00 CHF; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
7+ years GCP Quality Assurance experience
Global Health Authority inspection management
Risk-based inspection readiness strategy
Mock inspection facilitation and leadership
Regulatory compliance with FDA EMA PMDA
Nice-to-have
Strong mentorship and coaching capabilities
Excellent verbal and written communication skills
Ability to work in a fast-paced environment
Collaborative spirit across cross-functional teams
Strategic direction definition for quality systems
Key Requirements
+7 years experience in GCP-related QA function
Thorough understanding of international GCP standards