Qa Gcp Auditor

2+ years

Not Disclosed

London

10 Oct. 23, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary

Our European operations are expanding rapidly, and we are currently seeking a full-time QA GCP Auditor to join our Quality Assurance team. In this role, you will collaborate with a team to accomplish tasks and projects crucial to the company’s success. If you're looking for an exciting career that utilizes your GCP expertise and offers opportunities for personal growth, this is the position for you.

We are interested in candidates based in London, Munich, Leuven, or Warsaw. Hybrid working may be available depending on country policy after a six-month onboarding period.

Please submit applications in English.

Responsibilities

Act as a trusted partner with Medpace operations to promote a culture of continuous improvement.
Coordinate and conduct internal system audits and external site/vendor audits.
Create, maintain, and revise departmental Standard Operating Procedures, forms, and templates.
Develop training materials, applicable tests, and guides.
Collaborate with outside clients and sponsors.
Host sponsor audits and regulatory inspections.
Serve as QA Project Leader, managing timelines and coordinating workloads among QA Auditors.

Qualifications

Bachelor’s degree in life sciences or nursing.
At least 2 years of experience in a QA GCP department within a related industry.
Experience with GCP site and vendor audits is highly preferred.
Excellent written and verbal communication skills.
Strong teamwork abilities and the capacity to work independently.
Willingness to travel, averaging 50% across Europe.

About Medpace

Medpace is a full-service clinical contract research organization (CRO) providing 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 a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across key areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, and anti-viral and anti-infective treatments. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across more than 40 countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

Over the past 30+ years, our work has positively impacted countless patients and families facing various diseases. The efforts we make today will improve the lives of those living with illness in the future.

Medpace Perks

Hybrid work-from-home options (dependent on position and level)
Competitive PTO packages
Company-sponsored employee appreciation events
Health and wellness initiatives
Flexible work schedule
Competitive compensation and benefits package
Structured career paths with professional growth opportunities

Awards

Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024. Continually awarded CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.

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Qa Gcp Auditor

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