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. The role supports the commercial and late stage clinical cell therapy network for complex trend investigations stemming from deviations and SAEs. Leads cross-functional teams to close complex trend investigations, participates in strategic discussions, anticipates bottlenecks and risks, and collaborates 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 use 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 project.
Qualifications
- Bachelor's degree or equivalent in a relevant discipline with a minimum of 10 years of relevant experience; Master’s degree preferred but not required. Advanced degree time may be considered as equivalent experience.
- 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.
Skills
- Strong cross-functional collaboration and leadership in matrixed teams
- Analytical thinking and problem-solving for complex trend investigations
- Proficient project management and communication skills
Education
- Bachelor's degree required; Master's degree preferred
Additional Requirements
- On-site/occupancy considerations and travel as needed based on role design and site requirements