Clinical Quality & Risk Management Analyst

Job Locations United States-OH-Cincinnati
Category
Quality Assurance

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 approximately 3,500 people across almost 40 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 and Quality Event Management. This position will report to Sr. QA Manager Quality Event and Risk Management.

Responsibilities

The successful candidate will be responsible for facilitating 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 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 development of guidance, 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 Busines 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.

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 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.

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.

 

Awards:

  • Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
  • Recognized by Forbes as one of America's Best Mid-size Companies in 2021
  • Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

 

EO/AA Employer M/F/Disability/Vets

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*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money.  These scammers pose as legitimate employees from actual companies.  Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.

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