Significant Quality Event Lead
Groton, CT, United States On-site
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About the role
At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies. To work with and on behalf of Clinical Development Quality within DevOps, performing management Significant Quality Events. Significant Quality Event Lead: The individual responsible for the formation and leading of the Significant Quality Event Team and coordinating all activities related initiating immediate action, conducting Investigation/RCA, developing corrective and preventive actions, as needed, and documenting case activities within appropriate database. Conduct broader impacts across the Pfizer portfolio to share learning's with other impacted study teams. This position will include:
What you'll bring
- 3-5 years’ experience
- Root Cause Analysis
- Understanding of clinical trials
- Experience of leading global initiatives or project teams.
- Appreciation of diverse needs of different regulatory requirements of different sites and countries.
- Knowledge of quality requirements across a range of different countries
- Strong influencing skills with ability to influence a broad range of global stakeholders.
- Excellent communication skills adaptable to meet the needs of diverse stakeholder groups, internal and external.
- Record of achievement and delivery for personal and team goals.
- Ability to balance and prioritize a diverse and demanding workload.
- Works independently and proactively set own work agenda with minimum guidance
- ICH GCP, and Regulatory obligations