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Sr. Gcp Qa Auditor - Remote

5+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Medpace is seeking Quality Assurance (QA) Auditors to join their growing team. This role involves supporting and auditing global clinical trials in various therapeutic areas, ensuring compliance with organizational and regulatory standards. As a vital part of the QA department, this position will focus on maintaining high-quality standards for clinical trials and contribute to the development of the QA team’s success.

Responsibilities

  • Lead Quality Program: Act as the Quality Program Lead on clinical trials, ensuring compliance with national and international regulatory standards for pharmaceuticals, biologics, and medical devices.
  • Audit Management: Develop audit strategies and management plans with clients for ongoing clinical trials.
  • Conduct Audits: Perform internal system audits and external investigative site/vendor audits, ensuring adherence to Good Clinical Practice (GCP) guidelines.
  • Develop SOPs: Contribute to the development of standard operating procedures, work instructions, forms, and templates.
  • Assess Software Security: Evaluate the validated state and security of proprietary and cloud-based software systems.
  • Training Development: Create training materials and proficiency tests for company-wide regulatory training (ICH/GCP).

Qualifications

  • Educational Requirements: Bachelor's degree in life sciences or a related field.
  • Experience: At least 5 years of experience in a QA department within a related industry, including conducting audits of vendors and investigative sites.
  • Regulatory Expertise: Experience hosting regulatory authorities and interacting with sponsor/client representatives.
  • GCP Knowledge: Strong knowledge and application of Good Clinical Practice (GCP).
  • Additional Experience: Experience in Medical Devices and/or Phase 1 trials is a plus.
  • Travel: Ability to travel up to 30%-40% of the time.
  • Skills: Independent thinking, excellent written and verbal communication, and strong teamwork skills.

Medpace Overview

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. With a mission to accelerate the global development of safe and effective medical therapeutics, Medpace leverages local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, and more. Headquartered in Cincinnati, Ohio, the company employs more than 5,000 people across 40+ countries.

Why Medpace?

  • Impactful Work: Medpace has positively impacted the lives of patients across various therapeutic areas.
  • Perks: Flexible work environment, competitive PTO, company-sponsored events, wellness initiatives, and structured career paths.
  • Awards: Recognized as a Top Workplace in 2024 by The Cincinnati Enquirer and consistently named one of America's Most Successful Midsize Companies by Forbes.

What to Expect Next

A Medpace team member will review your qualifications. If you are selected, you will be contacted for the next steps.