Director Quality Management Late Development Oncology Clinical Operations (Americas)

Role: Oncology Clinical Quality Director (O-CQD) overseeing global clinical quality assurance within AstraZeneca’s oncology portfolio. Objectives: ensure compliance, embed quality frameworks, and mitigate risks in clinical operations. Responsibilities: lead and develop a geographically diverse team; build cross-functional partnerships; interpret complex data to monitor quality performance; advise on compliance and risk management strategies; support a culture of quality and continuous improvement; coordinate with global stakeholders and represent the function externally. Requirements: Bachelor’s or higher in a science field; ~10 years in clinical research quality/regulatory compliance; extensive knowledge of international regulations (FDA, EMA, PMDA, Health Canada), ICH-GCP, and GxP; experience in clinical study delivery and GxP-regulated environments; proven leadership and global stakeholder engagement skills; strong analytical and risk-based decision-making abilities. High-Value: focus on clinical quality management in GxP-regulated clinical research, with a deep understanding of international regulations and inspections. WorkSetup: not specified, but likely global/regional presence with cross-functional collaboration.