GCP QA Auditor

				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:

* Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics and medical devices.
* Develop audit management plans and audit strategy with clients for ongoing clinical trials.  
* Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines;
* Participate in the development of departmental standard operating procedures, work instructions, forms, and templates;
* Assess validated state and security of proprietary and cloud based software.  
* Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP);

Qualifications:

* Bachelor's degree in life sciences or related field; 
* 2-5 years of experience in a QA department in a related industry; 
* Experience conducting audits of vendors and investigative sites; 
* Experience hosting regulatory authorities and interacting with sponsor/client representatives; 
* Independent thinking and planning ability; 
* Knowledge and application of Good Clinical Practice (GCP) is required; 
* Medical Device and or Phase 1 experience is a plus; 
* Ability to travel up to 30%-40% of time; 
* Excellent written and verbal communication skills; 
* Exceptional teamwork skills; and 
* Ability to work independently.
			

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Medpace, Inc.

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