About this role
The successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders.
Responsibilities
- Coordinate and conduct internal process audits and external investigative site/vendor audits including laboratories (GCLP);
- Create, maintain, and revise departmental standard operating procedures, forms, and templates;
- Coordinate, conduct and track company-wide Regulatory training and Quality Event Management / CAPA
- Host audits by sponsors and regulatory inspectors;
- Coordinate, conduct, and track company-wide regulatory training ((Chinese) ICH GCP and medical device);
- Develop training materials and applicable tests and guides; and
- Work with outside clients/sponsors.
- Act as QA Project Leader, managing timelines and coordinating workload amongst QA Auditors
- Conduct Fraud and For Cause investigations and report to management.
Qualifications
- Bachelor’s degree in a related field
- Minimum 3 years of QA in GCP and GCLP auditing
- Used to work in an international team
- Willingness to travel (up to 50%)
- Fluent in English (verbally and in writing)
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.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Awards
- 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.
About Medpace
Full-service contract research organization providing clinical development services across therapeutic areas. Headquartered in Cincinnati, OH.
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