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 Director, Quality Assurance (QA) will act as a leader in the QA Department and will assist in overseeing all global QA processes, functions and employees. The ideal candidate will have 8+ years of experience in Quality Assurance (preferably within a CRO) and will possess strong knowledge of global GCP regulations and guidelines, including experience with Regulated Inspections, CAPA programs, Audit Management and applications of Part 11 to computerized systems used in Clinical trials. This position will be full-time.
Manage and lead regulatory inspections conducted at Medpace, the Sponsor and/or investigator sites;
Provide leadership and management of the Medpace QA Department;
Oversee internal process/system audits and external investigative site/ vendor audits;
Conduct and assist in the development of trainings on a company-wide basis;
Actively participate in the Medpace CAPA program, quality data analysis/trending and continuous process improvement initiatives;
Provide support and leadership in Sponsor audits;
Provide QA representation in project meetings, bid defenses and/or Sponsor governance activities, as needed;
Provide internal consulting to project-teams as needed; and
Collaborate with external clients and/or Sponsors.
Bachelor’s degree in Life Sciences;
Several years of experience in a QA department in a related industry;
Past supervisory experience; and
Expert knowledge of GCP Regulations and Guidelines as well as National Regulations and EU Directives within the EU member states.
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
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.
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