Clinical Quality & Risk Management Analyst

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 Event and Quality Risk Management. This position will preferably be based in our offices in Warsaw, Poland. Other European locations also an option or a home-based position may be considered too, depending on experience and expertise of the candidate.

The successful candidate will be responsible for facilitating the management of Quality Events and identification and evaluation of Quality Risks through application of Medpace’s Quality Event and Risk Management (QERM) program. 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 Quality Event Management (QEM) program through triage, and facilitating QEM steps such as problem definition, investigation, root cause analysis, CAPA planning and CAPA effectiveness driving continuous improvement of Quality Management System.

· Supporting further development systems, and tools to gather, organize, visualize, trend, and analyze data resulting from Sponsor Audits, Regulatory Inspections, Medpace Audits (Investigator Site, Vendor, Internal Process) and QEM Program and relevant external data sources.

· Developing and maintaining Quality Metrics to facilitate identification of potential trends and risks across Medpace Business Entities and providing actionable insights and recommendations to Process Owners and training and development teams.

· Leveraging risks at level of process / system to support proactive improvement of GxP regulated processes and systems and informing Medpace’s audit strategy and schedules.

· Supporting Process Owners with management of operational risks, including but not limited to risk identification, evaluation, control and/or monitoring strategies.

· Monitoring the effectiveness of CAPA and risk mitigation plans through internal process 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.

· Bachelor’s degree required (a more advanced degree preferred) in science or a related field.

· At least two (2) years of QA experience or at least 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). Position level will be determined based on experience of the candidate.

· 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 with 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.