Associate Director, Cell Therapy Network Investigations Lead
Bristol Myers Squibb
Full-time
Remote friendly (Devens, MA)
United States
Operations
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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’s 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.