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
Provide technical & program/project leadership to the project teams in all project phases (design, delivery, startup, commissioning, validation and operational support) as well as IS leadership oversight to ensure the program/project budget, schedule and staffing is commensurate to enabling the manufacturing automation and information systems to attain the performance standards required to support the business objectives.
April 10, 2023
Demonstrated leadership with strong communication skills and an ability to deliver the results through teamwork.
April 27, 2023
Tracks key service processes/service performance (Key KPIs will include first time fix rate, MTTR and MTBF, spares usage, connectivity, remote/predictive support) and drives improvement efforts.
May 06, 2023
