Experienced Quality Assurance (QA) Auditor - Global Inspections and Sponsor Audits
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.
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.
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
Bachelor's degree in science or a related field;
Three 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.
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.
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.
*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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