Company Description
GxP Engaged is a global leader in quality management auditing and consultancy services, specializing in all GxP domains. With a team of highly qualified and independent professionals, our services are rooted in the latest global and local regulatory requirements. We are known for our trusted independence, enabling unfiltered assessments to safeguard critical quality decisions. Through multi-GxP coverage at a global scale and a smart resourcing model, we deliver consistent and inspection-ready quality solutions. Leveraging advanced regulatory knowledge and technology-driven systems, we help clients navigate change, maintain control, and achieve compliance with confidence.
Role Description
The GCP Auditor will be responsible for conducting audits (investigator site audits, TMF audits, vendor audits, process audits etc.), ensuring compliance with Good Clinical Practice regulations and guidelines. This is a full-time role based in UK or Germany.
Day-to-day tasks include:
- Preparing, executing, and reporting on GCP audits
- Identifying risks and recommending corrective actions
- Supporting continuous improvement in quality systems
- Staying updated on evolving global regulatory requirements and industry best practices
Qualifications
- Thorough knowledge of Good Clinical Practice (GCP) guidelines, ICH regulations, and applicable global regulatory requirements
- Strong auditing skills, including planning, conducting, reporting, and follow-up of clinical site and quality system audits
- Excellent documentation, reporting, and organizational skills
- Effective communication skills, with the ability to collaborate across teams and work independently
- Relevant experience in clinical trial processes, regulatory audits, and compliance activities
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field (advanced degrees are advantageous)
- Knowledge of additional GxP domains or multilingual abilities is a plus
