Location: Cincinnati,OH, USA
Job Summary
The successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders.
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)
* Maintain the memorializing of frequently asked questions repository for regulatory inspection
* 25-30% Travel possible
Qualifications
* Bachelor's degree in science or a related field;
* 1-3 years of QA or five years of GxP regulated (GLP, GMP, GCP) industry experience;
* 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;
* The ability to work well on a team as well as independently.
Medpace 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.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
* Cincinnati Campus Overview
* Hybrid work-from-home options (dependent upon position and level)
* Competitive PTO packages, starting at 20+ days
* Competitive compensation and benefits package
* Flexible work schedule
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Discounts on local sports games, fitness gyms and attractions
* Modern, ecofriendly campus with an on-site fitness center
* Structured career paths with opportunities for professional growth
* Discounted tuition for UC online programs
Awards
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets