Senior Manager, Cell Therapy Network Lead Investigator

About This Role

Serve as the lead investigator for global trend investigations and global Serious Adverse Events (SAEs) within the commercial and late-stage clinical cell therapy network. This role involves leading cross-functional teams to resolve complex investigations and CAPAs.

Responsibilities

• Serve as lead investigator for 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

Requirements

• 5+ years of relevant experience in a relevant discipline
• 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

Qualifications

• Bachelor's degree or equivalent in a relevant discipline
• Minimum of 5 years of relevant experience; time spent in advanced degree programs may be considered as equivalent relevant experience

Nice to Have

• Master's degree
• Green Belt or Black Belt certification

Skills

* Required skills

Benefits