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

Job Summary

This critical leadership role requires a Director to oversee Clinical Quality Assurance Compliance across global clinical development programs, ensuring strict adherence to Good Clinical Practice (GCP) and international regulatory requirements (ICH, FDA, EMA). The Director will be instrumental in developing and implementing a proactive, risk-based quality strategy, guaranteeing continuous inspection readiness, and managing quality risks and remediation efforts, including CAPAs. Responsibilities include collaborating with internal teams and external vendors (CROs) to review key study documentation and manage Quality Agreements. Furthermore, the role involves leading and developing a team, fostering a robust culture of quality, and driving continuous improvement across the Global Development Organization. Candidates must possess a university degree in life sciences, over 10 years of professional experience in a GCP-regulated environment, strong strategic leadership skills, and fluency in English.