Senior Associate, Quality Assurance
vor 2 Monaten
For our office in Munich (in a hybrid working model) we are recruiting for a
**Senior Associate, Quality Assurance (f/m/d)**
The Senior Associate, Quality Assurance (f/m/d) for the German Affiliate is dedicated to providing comprehensive support to the Responsible Person in accordance with -52a AMG, -2(1) of the German GDP regulation (AM-HandelsV), and EU-GDP guidelines, ensuring strict compliance with GDP license requirements. The responsibilities include recognizing, documenting, and executing deviations, Corrective and Preventive Actions (CAPAs), and change controls as well as reporting adverse events and technical product complaints to the relevant department or service provider responsible for processing reports, in accordance with local Standard Operating Procedures (SOPs).
This role serves as a vital link in maintaining adherence to regulatory standards and ensuring the integrity of pharmaceutical operations within the German Affiliate.
**What you'll do**
- ** 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
**Who you are**
You possess a meticulous attention to detail coupled with a proactive approach to problem-solving, effective communication skills and the ability to collaborate seamlessly with cross-functional teams. You foster a culture of continuous improvement and excellence in quality assurance practices.
**Qualifications**
- Preferably Master Degree in Pharmacy, or equivalent, as per Section 15 AMG
- Min. 2 years of** **experience within quality/or related functions in pharma/biotech/life sciences
- Knowledge of Directive 2011/62/EC (FMD) in conjunction with Commission Delegated Regulation (EU) 2016/161, AMG 2024 and Good Distribution Practice preferred
- Ability to set priorities and work independently
- Organized and structured working method
- Ability to work within predefined processes
- Fluency in German and English
**Additional Information**
**Why Biogen?**
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts
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