Director, Clinical Quality Assurance Compliance | Biologist (m/w/d)

Job Summary

This senior leadership role requires a Director of Clinical Quality Assurance Compliance to spearhead global QA activities across clinical development programs. The Director is responsible for developing and executing a proactive, risk-based quality strategy, ensuring continuous GCP compliance, and maintaining inspection readiness for high-priority trials. Key daily tasks include collaborating with internal teams and external vendors (CROs) to investigate and remediate quality issues, reviewing critical study documentation, and managing Quality Agreements. Crucially, the role involves leading and developing a team while driving a pervasive culture of quality and continuous improvement throughout the Global Development Organization. Candidates must possess a university degree in life sciences, over ten years of profound experience in a GCP-regulated environment, and strong expertise in global clinical regulations (ICH, FDA, EMA), coupled with experience managing regulatory authority inspections.