Director Quality Management, Late Development Oncology Clinical Operations
Core
Lead and oversee the Quality Management function for Late Development Oncology Clinical Operations, ensuring compliance with international regulations and driving a quality mindset across global teams.
Role type
Senior Director, Clinical Quality Management
Builds
Quality frameworks, risk management approaches, and compliance strategies for oncology clinical trials
Domain
Pharmaceutical industry, Oncology, Clinical Research, GxP-regulated environment
Required skills
International clinical regulations (ICH-GCP, FDA, EMEA), Clinical trial quality management, Risk-based decision-making, Team leadership and coaching, Strategic partnership building, Data interpretation for quality performance, Global regulatory compliance, Drug development process knowledge
Preferred skills
Experience with global regulators (FDA, PMDA, Health Canada), Audit and inspection management, Cross-functional collaboration, Conflict resolution
Technologies
GxP systems, Clinical trial management systems, Quality management software
Responsibilities
Lead, develop, and coach a geographically diverse team of quality professionals; Embed quality frameworks and risk management approaches with senior leadership; Interpret complex data to assess quality performance and recommend compliance improvements; Provide expert quality advice on complex compliance matters and risk mitigation; Lead Quality Management Reviews to communicate key compliance insights; Act as the interface with global stakeholders (legal, ethics, GxP); Represent the function in external expert groups
Seniority
Director, strategic leadership with hands-on oversight