Associate Director, Cell Therapy Network Investigations Lead

Role Summary

Cell Therapy Investigations lead will support the commercial and late-stage clinical cell therapy network for complex trend investigations stemming from deviations and SAEs. The lead investigator will assemble and lead cross-functional matrix teams necessary to close complex trend investigations. They will participate in strategic discussions, anticipate bottlenecks and technical risks, and address issues proactively while fostering teamwork. The role requires collaboration with SMEs, user groups, quality groups, and other stakeholders to complete complex trend deviations and CAPAs.

Responsibilities

• Develop and execute standard work and communication plans for trend investigations, ensuring communication across all impacted manufacturing sites and technical stakeholders, and using consistent tools for root cause analysis, CAPA identification, and documentation.
• Serve as the interface between sites, product teams and laboratories, ensuring a consistent approach to trend investigations.
• 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 project management techniques and tools appropriate for the given project.

Qualifications

• Required: Bachelor's degree or equivalent in relevant discipline with a minimum of 10 years of relevant experience.
• Preferred: Masters degree (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience.
• Preferred: Green Belt or Black Belt is preferred but not required.
• Required: Expert understanding of cGMP regulations and/or business and documentation processes.
• Required: Expert in root cause analysis, CAPA and risk mitigation.
• Required: Proficient in project and portfolio management skills.