Senior Auditor R&D Quality (all gender)

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. 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.



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%.



SThree_Germany is acting as an Employment Business in relation to this vacancy.