Research & Development Quality Management System
vor 2 Wochen
**Job Description**:
For our Munich office (in a hybrid working model) we are recruiting for a
**Research & Development Quality Management System Coordinator DACH (f/m/d)**
- employed via third party provider for 12 months
- **About this role**
The position is accountable for the Research & Development (R&D) Quality Management System (QMS) support of multiple countries (Switzerland, Austria, Germany) with individual regulations and license requirements. The person will be driving the project coordination of R&D QMS implementation, oversight on R&D QMS related topics and provide input for establishment of Quality objectives and goals.
**What You'll Do**
- Ensure proper implementation of the R&D QMS within the DACH region
- Oversee and update R&D related SOPs within the DACH region
- Coordination and alignment with regards to the R&D QMS project between the affiliates and global functions as main contact
- Collaboration with local FLLs and QA departments
- Establish GAP assessments with SMEs
- Local KPI definition and standardized templates to share with affiliates
- Deviation and CAPA management
- Audit /inspection coordination and support
**Who You Are**
You are an open and dynamic person, ready to grow and succeed in a complex environment. You are always striving to challenge the status quo as well as to optimize existing processes and procedures.
**Qualifications**:
**Required Skills**:
- Degree in life sciences or advanced experience in R&D related areas within the pharmaceutical/biotech industry
- Min. 3 years of relevant working experience in Quality/R&D related areas within the pharmaceutical/biotech industry
- Deep knowledge of Quality Management Systems and relevant legal requirements within the DACH region
- Proven experience working cross-functionally, leveraging their leadership skills, to influence and drive results within the matrix organization.
- Fluent in German and English
- Proofed ability to work in complex cross functional teams
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.
**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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