Provides quality assurance oversight of the global and local clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU), and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.
Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice.
Defines and implements a risk-based program audit strategy, ensuring the communication of significant quality and compliance risks to key stakeholders and Management, and ensuring appropriate and timely investigations and mitigations are in place
Leads the inspection readiness programs, the management of the inspection, and the response and follow-up activities. Ensures that inspection ri...
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