Associate Director, Quality Risk Specialist (GCP)
Bristol Myers Squibb
📍 boudry, neuchâtel, Switzerland
Job Description
Description
The Associate Director, RBQM will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.
Key Responsibilities:
Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
As part of the upstream protocol authoring process, partner with Drug Development, to embed Quality by Design principles and help identify study specific critic...