Quality Assurance (QA) Associate - Global Inspections and Sponsor Audits

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

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;
* Conduct mock interviews for subject matter experts (SMEs) during inspection preparation;
* Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA);
* Manage training for Medpace stakeholders with respect to inspection readiness;
* Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk;
* Act as QA lead for inspections at Medpace;
* Provide as needed support for inspections at Medpace external clients (sponsors and investigator sites); and
* Maintain the memorializing of frequently asked questions repository for regulatory inspection.

Qualifications:

* Bachelor's degree in science or a related field;
* Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA);
* Strong communication skills;
* Strong quality mindset;
* Experience in supporting or conducting audits;
* Excellent written and verbal communications skills in English;
* Independent thinking and planning ability;
* Experience with a wide range of computerized systems;
* Good time management skills;
* Ability to switch between both big picture view and attention to detail; and
* The ability to work well on a team as well as independently.
			

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