Specialist, Qa Clinical Auditor

J&J FAMILY OF COMPANIES

Allschwil, Basel-Country, Switzerland
Hybrid
Gcp qa routine audits
Clinical investigator site audits
External service provider audits
Johnson & Johnson is seeking a Specialist, QA Clinical Auditor to conduct and report on GCP QA audits across multiple locations in Europe. The ideal candidate will have a background in Clinical Quality & Compliance and be proficient in Good Clinical Practices, with a focus on ensuring adherence to regulatory requirements

Job Summary

  • As a Specialist, QA Clinical Auditor you will lead the planning, conduct and reporting of GCP QA routine audits and support non-routine GCP audits to assure adherence to corporate policies and compliance with applicable regulatory requirements.
  • You will analyze, interpret data and identify patterns and trends, ensure timely and appropriate review & delivery of CAPAs and actions arising from audits, and present information logically and concisely, both verbally and in writing.
  • This hybrid role requires a minimum of a Bachelor’s degree, experience in Clinical Quality & Compliance, Clinical Operations, and/or related R&D area, and knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Specialist, QA Clinical Auditor to conduct and report on GCP QA audits across multiple locations in Europe. The ideal candidate will have a background in Clinical Quality & Compliance and be proficient in Good Clinical Practices, with a focus on ensuring adherence to regulatory requirements.

Skills & Requirements

Must-have

  • GCP QA routine audits
  • Clinical Investigator Site audits
  • External Service Provider audits
  • Process/System audits
  • Local Operating Country audits
  • GCP and applicable regulations/guidelines

Nice-to-have

  • risk-based auditing approach
  • data analysis and interpretation
  • CAPA review and delivery
  • regulatory inspection support
  • training material development

Key Requirements

  • Bachelor's degree required
  • Advanced degree preferred
  • Experience in Clinical Quality & Compliance
  • Knowledge of drug development process
  • Knowledge of GCP and regulations
  • Understanding of clinical trial risk management
  • Digital literacy & Analytics experience
  • Ability to plan and prioritize work
  • Speak and write in English

Work Rights

Not specified

Tailored Resume

Cover Letter