Lead the Quality Center of Expertise (COE) for GPD with accountability to assure the Good Clinical Practices (GCP) quality of clinical trial execution, ensuring quality standards, monitoring of quality performance metrics and effective deviation and CAPA management.
November 11, 2022
Collaborate with Technical Operations to understand existing production issues and modify testing strategies to incorporate cases to prevent reoccurring production issues.
January 10, 2023
Evaluate quality events/incidents/issues and perform risk analysis, identify remediation actions and communicate to management or other stakeholders, as appropriate.
January 14, 2023
Develop, implement and maintain a GxP audit and monitoring plan, including establishment and management of related SOPs, a risk-based audit and monitoring schedule, and a CAPA effectiveness program.
March 05, 2023
Understanding of scientific methods and the ability to interpret and communicate scientific data internally and externally.
March 23, 2023
Act as the subject matter expert (SME) for optimization of new or existing products, processes, techniques, procedures or facilities/equipment to ensure compliance with quality criteria.
April 01, 2023
Manages the operational interface, coordinating engineering resources and optimizing and driving adherence to common global processes (including spare part management, case management, documentation, escalation management & quality management) across and aligned with the other business lines.
April 09, 2023