Head of Global GxP Quality System and Compliance

The Global GxP Quality Systems Head is accountable for working collaboratively across the organization (at global and local level) to develop and implement of an enterprise-wide Quality and Compliance strategy covering end-to-end regulated processes conducted by Sobi functions, Affiliates, service providers and partners to assure adherence to global health authority requirements across the product lifecycle.

• Leading Global GxP Compliance & Quality Systems team
• Responsible for advancing a Quality &Compliance mind set and has a unique opportunity to lead transformational change to a culture of excellence and working across the Global Quality organization to streamline and simplify by taking an end-to-end integrated approach to quality and compliance across the product lifecycle
• Responsible for the effectiveness and sustainability of Global Sobi Quality Management System at global and local level
• Responsible to oversee the quality system and ensure compliance with current GxP and regulatory requirements
• Responsible to establish and maintain budget and timelines as well as supervise the implementation and maintenance of quality relevant processes
• Responsible to provide leadership and strategic direction to teams working within GxP relevant activities to ensure adherence to the principles and processes of the quality strategy and take actions where needed to ensure company wide compliance
• Responsible to oversee of quality relevant processes, and in conjunction with the Global Process Owners identify areas of improvement and implement steps to improve them with a continuous focus on improving strategies and tools
• Responsible for the development, implementation and sustainability of risk management process for timely identification and reporting of risks to maintain a concept of Quality Risk Management
• Accountable for the definition and approval of Annual Audit Programs and preparation, conduction/host and follow up of internal audits and regulatory inspections
• Responsible to provide strategic direction and report performance of the quality system and related procedures to Sobi Senior Leaders Officer on a regular basis and initiate preventive and corrective actions to avoid recurrence of deviations/non-conformances