Senior Auditor R&D Quality (all gender)

Progressive; Frankfurt; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading pharmaceuticals company in Frankfurt is seeking a Senior Auditor for R&D Quality to ensure compliance and operational excellence in clinical development. The ideal candidate will have over 10 years of experience in Clinical Quality Assurance, including 5+ years as a GCP Auditor. Responsibilities include conducting GCP audits, developing audit plans, and maintaining high-quality standards across clinical operations. A degree in natural sciences, pharmacy, or medicine is required. Willingness to travel up to 20% is needed.

Qualifikationen

• 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 and attention to detail.

Aufgaben

• 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.
• Act as QA Business Partner and provide expert guidance on GCP and quality matters.

Kenntnisse

Clinical Quality Assurance

GCP Auditing

Risk-based audit planning

Stakeholder management

Analytical skills

Ausbildung

Degree in natural sciences, pharmacy, or medicine

Jobbeschreibung

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.