Dominik Otter

Leading a production team of about 150 employees responsible for the assembly and packaging of autoinjector systems. Drive performance to ensure market supply of autoinjectors, with a primary focus on Dupixent and new product launches. Drive a cultural shift in change management and the Play to Win strategy, with a strong focus on taking initiative and acting independently.

Responsible for a production area dedicated to the assembly and packaging of autoinjectors and insulin pens. Ensure that products are manufactured and stored in compliance with applicable SOPs and regulations. Drive continuous improvement in manufacturing with the goal of increasing performance and OEE.

Leading a QC laboratory team of about 25 employees responsible for testing and releasing insulin pens. Contributing and supporting various projects and product launches by establishing new testing methods and performing batch release tests. Advancing performance and efficiency through participation in the Fit4Future transformation program as well as expansion and enhancement of the shift system and testing capacities.

Responsible for all supplier activities within the U300sc project as QA focal point. Accountable for the qualification & validation activities at the supplier as well as for deviation, CAPA- and change control management. Quality representative and main SME for FDA inspection readiness, including preparation and execution.

Responsible QA Manager for existing components and sub-assemblies within the framework of supplier management. Coordination of Quality Assurance Agreements with external contractors/partners. Representing Sanofi in compliance and performance meetings.

Responsible QA Manager for supplier management. Responsible for internal and external audit management and represent the company in customer audits.