Global GCP Auditor
- Experience Level
- Senior Management
Our client one of the top pharmaceutical companies globally with an excellent team and portfolio are looking for a GCP Auditor to perform Good Clinical Practice (GCP) related audits in the areas of Clinical Operations, Medical Affairs, Regulatory Affairs, Translational Medicine, Biometrics and Data Management in various European countries. In more detail, this includes system and process audits, audits at clinical sites and at Operating Units at the country and regional level, computer system validation audits as well as quality system audits at CROs and other service providers.
Being part of the global QM organization you are a competent partner to our business functions. As we aim for excellence in quality, you will guide them to manage and oversee the quality of their work.
Tasks & responsibilities
Beyond performing GCP related audits your responsibilities include to:
Support the organization in implementation and follow-up of corrective and preventive actions.
Provide our business functions with QA and GCP guidance.
Understand quality by design and implement a risk-based approach in auditing process.
Prepare for and participate in regulatory inspections.
Share best practices and ideas with fellow auditors on international level
Master’s degree (or equivalent) in medicine, pharmacy, life science, or any other relevant field
Approximately 3-5 years’ experience in clinical trials with preferably 5 years’ experience in GCP Auditing
In-depth knowledge of GCP regulations and legal requirements, ideally also experience in quality management and computer system validation
Being able to review and analyze essential documents thoroughly and critically
Good communication skills in English (verbal and in writing), German language skills would be an asset
Well-developed interpersonal skills are required. Open-minded and reliable personality, and being able to work independently as well as in a team
Willingness to travel (inter)nationally, up to a maximum of 40%
Want to find out more and APPLY NOW?
This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to “sebastian” at sdiez (at) barringtonjames (dot) com alongside a copy of your CV.