Medpace needs to facilitate sponsor audits, regulatory inspections (FDA, EMA, MHRA), and manage QA relationships with external clients, while also conducting inspection readiness activities for Medpace and its stakeholders.
Requirements
- Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA)
- Experience in supporting or conducting audits
- Experience with a wide range of computerized systems
Responsibilities
- Facilitating Medpace sponsor audits onsite
- Review and assess responses to sponsor audit reports
- Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits
- Provide guidance to Medpace study teams during sponsor audits
- Manage pre-inspection activities for Medpace inspections
- Provide inspection data trends to the Quality Metrics group for executive management review
- Manage the inspection backroom during regulatory inspections to facilitate the timely delivery of requested documents
Other
- Bachelor’s degree in science or a related field
- Strong communication skills
- Strong quality mindset
- Excellent written and verbal communications skills in English
- Independent thinking and planning ability
