Associate Director, Cell Therapy Network Investigations Lead

Role Summary

Associate Director, Cell Therapy Network Investigations Lead. Lead complex trend investigations across the commercial and late-stage clinical cell therapy network, assembling cross-functional teams to close investigations, anticipate bottlenecks and risks, and collaborate with SMEs, quality groups, and stakeholders to complete deviations and CAPAs.

Responsibilities

• Develop and execute standard work and communication plans for trend investigations across manufacturing sites and stakeholders, using consistent tools for 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.
• Act 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.

Qualifications

• Bachelor's degree or equivalent in a relevant discipline with a minimum of 10 years of relevant experience; master's degree preferred (time in advanced degree programs may be considered as equivalent experience).
• Green Belt or Black Belt 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.

Skills

• Cross-functional leadership
• Deviations and CAPA management
• Root cause analysis and risk assessment
• Project management and portfolio management
• Communication across manufacturing sites and technical stakeholders

Education

• Bachelor's degree required; Master's degree preferred in a relevant discipline.

Additional Requirements

• On-site/field travel as required by role responsibilities may be implied by site and project needs.