Clinical Quality Risk Management Analyst

Job Description

Overview

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,000 people across 36 countries.

Job Summary

We are looking to strengthen the Global Quality Assurance (QA) team with an experienced QA professional supporting continuous improvement of Medpace’s Quality Management System through application of Quality Risk Management. This position will report to QA Manager Quality Risk Management and will be based in one of the following Medpace offices: Leuven (Brussels), London, Munich, Lyon, Warsaw, Maastricht, Milan, Prague, Cincinnati, or Dallas. Other locations may be considered too, depending on experience and expertise of the candidate.

Responsibilities

The successful candidate will be responsible for facilitating management of Quality Events and Quality Risks through application of Medpace’s Quality Event Management (QEM) program, and the analysis of data. Translating data into knowledge and making best use of knowledge are essential to achieving Medpace’s mission of accelerating the global development of safe and effective medical therapeutics.

• Supporting Medpace’s QEM program through triage, problem definition, investigation, root cause analysis, CAPA planning and CAPA effectiveness driving continuous improvement of Quality Management System
• Supporting development of guidance, systems, and tools to gather, organize, visualize, trend and analyze data resulting from Sponsor Audits, Regulatory Inspections, Medpace’s Audit and QEM Programs and relevant external data sources
• Developing Quality Metrics to facilitate identification of potential trends, risks and actionable insights
• Leveraging risks at Quality System level to support continuous proactive improvement of GxP regulated processes and informing the audit strategy
• Supporting risk owners with management of operational risks, including but not limited to risk assessment, risk control and/or risk monitoring strategies
• Monitoring the effectiveness of CAPA and risk mitigation plans through internal audits
• Disseminating knowledge to Medpace stakeholders through training and education
• Supporting maintenance and development of a risk based Quality Management System, including creation, revision or periodic review of Standard Operating Procedures;

Qualifications

• Bachelor’s degree required (a more advanced degree preferred) in science or a related field;
• Two (2) years of QA experience or four (4) years of operational experience in a GCP regulated environment (a combination of experience in GxP regulated environment, including GCP will also be considered);
• Experience in problem solving through investigation, root cause analysis and CAPA planning
• Experience in Quality Risk Management is a plus;
• Strong analytical skills;
• Strong quality mindset;
• Excellent written and verbal communications skills in English;
• Independent thinking and planning ability;
• Experience with a wide range of computerized systems including MS Office (experience Business Intelligence tools is a plus);
• Good time management skills;
• Ability to switch between both big picture view and attention to detail;
• Ability to develop strong collaborative working relationships with key stakeholders;
• The ability to work well on a team as well as independently

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.