Quality Process Lead Europe. Job in Bern German Careers - CSL Behring

Beschreibung

General Summary:

CSL Behring is a leading global biotech company committed to its promise to save lives. The products are manufactured at multiple sides worldwide. Within the Business Process Organization we are looking for a Quality Process Lead for Europe that is responsible for the electronic systems and the corresponding processes for the Quality organization in this region.

Main Responsibilities:

• Leading the implementation and improvements of Quality processes in the European region using SAP Modules (QM/EBR/ECP), Power BI and RPA solutions based on leading practice and in compliance with regulatory requirements.
• Define best practices together with the Quality Process Leads of the other sites and the Global Quality Process Lead.
• Take ownership of the globally aligned processes for the European region.
• Ensure that the Quality processes at the European sites adhere to the global standards.
• Support and/or lead business process projects and initiatives (e.g. Country Specific Planning and Release, Introduction of new CMOs, Launch of new products, new reporting solutions, introduction/change of 3PL provider or affiliate).
• Interact with global and local Functional Leaders to align on priorities, hot topics and required actions to improve process efficiencies.
• Act as primary operational contact for the European sites for issue investigation and resolution, requirements gathering from the business, testing of system changes and coordination of routine update or other meetings. This also involves working and communicating closely with the I&T team.
• Support global Quality Process Lead on continuous improvement with roadmap and prioritization, ensuring Value realization in the region and if possible, at global scale via analytics, KPIs etc.
• Create and cultivate a regional network of Process Experts/SMEs across the region/area/countries to drive process performance and improve user adoption.
• Having regular conversations with regional functional leads to achieve alignment on project roadmaps and improvement opportunities.
• Driving positive, digital and data driven cultural development within the organization through awareness, organization, change management and sharing the importance of reliability and digital Quality Management capabilities.
• Act as change agent for the respective business area.
• Develop and maintain training and SOPs to address user needs for the relevant processes.
• Identify adequate KPI's which indicate the efficiency of the current and future process to measure the performance of the current process and benefit of improvements.

Education:

Bachelor's or master's degree in Quality Management, Engineering, Life Sciences or related field. MBA a plus

Experience:

• Five to ten years of experience in Quality Management, Supply Chain Management Operations or related field. Experience within pharmaceutical or regulated industry preferred
• 3+ years' experience with ERP. SAP proficiency is strongly preferred.
• Experience with reporting systems (e.g. SAP QM, MS PowerPlatform).
• Excellent knowledge of quality processes including integration with planning- and execution systems
• Agile mindset
• Knowledge of pharmaceutical / biological manufacturing, GxP and regulatory standards, and environments.
• Experience with setting up paginated reports and dashboards within PowerBI is a plus.

Language:

Fluency in German and English is required.

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.