Associate Director, Cell Therapy Network Investigations Lead

Role Summary

Associate Director, Cell Therapy Network Investigations Lead. Lead investigations of complex trend deviations and SAEs across commercial and late-stage clinical cell therapy networks, assembling cross-functional teams and coordinating global trend investigations and CAPAs.

Responsibilities

• Develop and execute standard work and communication plans for trend investigations across all impacted sites and stakeholders, including root cause analysis, CAPA identification, and documentation.
• Serve as the interface between sites, product teams, and laboratories to ensure a consistent approach to trend investigations.
• Lead global trend investigations and global SAE events; support site-based investigators for complex trend investigations.
• Manage complex cross-functional projects/programs using appropriate project management techniques and tools.

Qualifications

• Bachelor's degree or equivalent in a relevant discipline with a minimum of 10 years of relevant experience; Master‚Äôs preferred but not required.
• Green Belt or Black Belt is preferred but not required.
• Expert understanding of cGMP regulations and/or business and documentation processes.
• Expert in root cause analysis, CAPA, and risk mitigation.
• Proficient in project and portfolio management skills.