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Qa Gcp Auditor

2+ years
Not Disclosed
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 seeking a full-time QA GCP Auditor to join our Quality Assurance team. This role involves collaborating on key tasks and projects that are vital to the company’s success. If you're looking for an exciting career that leverages your GCP expertise and allows for personal growth, this is the opportunity for you.

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

Please submit applications in English.

Responsibilities

  • Partner with Medpace operations to foster 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, tests, and guides.
  • Collaborate with outside clients/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.
  • Minimum of 2 years of experience in a QA department within a related industry.
  • Experience with GCP site and vendor audits.
  • 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.

The work we've done over the past 30+ years has positively impacted countless patients and families facing various diseases. Our efforts today will improve the lives of those living with illness and disease 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.