This role serves as the embedded clinical quality voice for sponsor clients, overseeing CROs and ensuring inspection-ready status against global regulatory expectations
Job Summary
This role serves as the embedded clinical quality voice for sponsor clients, overseeing CROs and ensuring inspection-ready status against global regulatory expectations.
The position requires independently establishing and executing sponsor oversight programs aligned with ICH E6(R3) while authoring quality agreements with vendors.
Syner-G offers a life-enhancing career culture recognized by BioSpace's 'Best Places to Work' award, emphasizing growth, learning, and meaningful impact.
Matching Summary
This role serves as the embedded clinical quality voice for sponsor clients, overseeing CROs and ensuring inspection-ready status against global regulatory expectations.
Skills & Requirements
Must-have
GCP quality and compliance engagements
Sponsor oversight programs for clinical trials
ICH E6(R3) risk-based quality oversight
Independent GCP audit planning and execution
Pre-approval inspection readiness preparation
Nice-to-have
Experience with virtual and emerging biotechs
Strong client-facing communication skills
Strategic decision-making judgment
Knowledge of FDA and EMA regulations
Ability to lead without direct people management
Key Requirements
Experienced clinical quality professional
Phase 1 through Phase 3 clinical program experience