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Chief Risk Management Officer
vor 2 Wochen
Bristol Myers Squibb SA is a leading biopharmaceutical company that transforms the lives of patients by developing innovative treatments. We are seeking a highly skilled and experienced professional to join our team as an Associate Director, Quality Risk Specialist.
About the RoleThis role will be responsible for developing the quality narrative at the study and/or asset level to document end-to-end risk-based quality management for critical to quality data, processes, and vendors. The successful candidate will provide quality and compliance consultation to clinical trials teams throughout the study lifecycle and ensure mitigation strategies are adjusted when new or unanticipated issues arise.
- Develop the quality narrative (or equivalent) at a study and/or asset level to document end-to-end risk-based quality management for CtQ data, processes, and vendors.
- Partner with drug development teams to embed quality by design principles and identify study-specific critical to quality data, processes, and vendors.
- Provide feedback on risks to study-specific critical to quality factors and ensure mitigation strategies are adjusted as needed.
- Conduct spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
Key Responsibilities
The ideal candidate will have a strong background in risk-based quality management and experience working in a similar role. They will also possess excellent communication and problem-solving skills, as well as the ability to manage complex assignments effectively.