Senior Associate, Quality Assurance (f/m/d)

at  Biogen

Job Description
For our office in Munich (in a hybrid working model) we are recruiting for a

• Support the Responsible Person on the maintenance of the Local Quality Management System consisten with in-country requirements and Biogen QMS:
• Back-up for Quality Management Review coordinator
• Local implementation and alignment of Global Quality Management Systems (Global Directives).
• Training plan review and support of training assignments
• Performing the revision for local Quality controlled documents within the documentation management system for local procedures
• Support the Responsible Person on the maintenance of German Wholesaler Distribution Authorization, and Marketing Authorization
• Ensures that suppliers are qualified
• Ensures that customers are qualified in coordination with responsible departments and third party service providers
• Manage return requests and perform a first assessment
• Is up-to-date with cGDP and German regulatory requirements
• Supports GMP/GDP-related Audits and Inspections:
• Supports GDP inspections with preparation readiness and required follow-up and CAPA implementation in close collaboration with the RP.
• Supports Affiliate Audits and coordinates related follow up and CAPA implementation in close collaboration with the RP
• Ensures that corrective and preventive actions are introduced as outcome of self-inspections performed at the German affiliate
• Product and Distribution related issues as Deputy Responsible Person - Germany:
• Support Product Recall and local mock recall exercises.
• Supports Technical Product Complaint related investigations, follow-up as necessary and replacement requests.
• Ensures that suspected falsified product is immediately notified for investigation and supports coordination of local management.
• Supports the Responsible Person to ensure that all communication to the authorities is appropriate, coordinated and approved.
• Supports temperature excursion assessments within Germany