QA Auditor

2 weeks ago

Singapore Medpace, Inc. Full time

Job Summary:

- Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Quality Assurance (QA) Auditor to join our team in Singapore. The QA Auditor will play an essential role in ensuring that Medpace upholds a standard for excellence by providing accurate, consistent and reliable regulatory guidance. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities:

- Coordinate and conduct internal process audits and external investigative site/vendor audits including laboratories;
- 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 (ICH/GCP and medical device);
- Develop training materials and applicable tests and guides; and
- Work with outside clients/sponsors.

Qualifications:

- Bachelor’s degree in life sciences or a related field;
- At least 2 years of experience in a QA department in a related industry;
- Experience conducting audits of vendors and investigative sites
- Experience hosting regulatory inspections and sponsor audits;
- Ability to travel up to 30%-40% of time;
- Excellent written and verbal communication skills; and
- Able to work well on a global 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 4,500 people across almost 40 countries.

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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