Das ist der Job
SThree_Germany is acting as an Employment Business in relation to this vacancy.
Darum lohnt es sich
In this role, you will independently plan and conduct GCP audits, support the R&D Quality Management System, and partner closely with Clinical Operations and R&D teams to maintain the highest quality standards.
Senior Auditor R&D Quality (all genders)
About the Role:
We are seeking a Senior Auditor (R&D Quality) who will play a key role in ensuring compliance, quality, and operational excellence across our clinical development portfolio.
Your Responsibilities:
• Conduct GCP audits for investigator sites, clinical studies, internal processes, and clinical vendors.
• Develop risk‑based audit plans and ensure timely follow‑up of findings and CAPAs.
• Support and enhance R&D‑relevant Quality Management System processes (SOPs, deviations, documentation).
• Act as QA Business Partner to Clinical Operations, providing expert guidance on GCP and quality matters.
• Audit and qualify key clinical suppliers such as CROs, labs, depots, and logistics partners.
• Support inspection readiness and contribute to internal training on GCP and quality topics.
What You Bring:
• Degree in natural sciences, pharmacy, or medicine.
• 10+ years in Clinical Quality Assurance; 5+ years as a GCP Auditor in pharma or medical devices.
• Strong knowledge of ICH‑GCP and ISO 14155.
• Excellent analytical skills, attention to detail, and a structured way of working.
• Confident communicator with strong stakeholder management skills.
• Willingness to travel up to 20%.
