Global External Quality Technical Team Lead
vor 23 Stunden
Job Description**
About This Role**
In this function you will lead the Global External Quality Technical team in relation to daily activities.
You will provide support in Global External Quality (GEQ), Quality Systems, Program Management, CMO processes, and Release documentation activities for all commercial and clinical products (incl. external and internal Deviations, CAPAs and Change Controls, as well as performs transactions in the IT Quality systems that are under the Quality Oversight of GEQ organization.
The role also includes leading and supporting projects and process improvements impacting the GEQ processes as well as acts as BPO for GEQ owned processes (e.g. CMO Management).
In this role you will also provide support during product market launch activities (project management support, GCCs etc.) as well as lead/support projects from a systems perspective (e. g support in continuous improvement initiatives, global processes alignment, regulatory intelligence actions implementation for internal and external processes etc.).
Qualifications**
What You’ll Do**:
- Manage the Global External Quality Technical Team: Ensure training of the team and development of the team members.
- Support the Global External Quality organization as required in the management of Quality operations and Quality system activities including system follow up of deviations, CAPAs, and change controls (internal and external including Market launch activities), as well as the Authorization to Manufacture and product Transport approvals under the responsibility of Global External Quality.
- Lead projects, and global processes alignment (internal and external) as well as continuous improvement initiatives, regulatory intelligence actions monitoring and implementation.
- Perform resource allocation analysis for the Global External Quality organization on a monthly basis and communicate results and associates resource allocation actions (assignment of team support) to Global External Quality Leadership Team.
- Manages preparation and execution of Quality Management Reviews (global, Baar & CAM sites).
- Act as QA contact for IT Quality systems enhancements and business processes updates as needed.
**Who You Are**
**Required Skills**:
- Diploma/BS in Biochemistry, Microbiology, Chemical/Biochemical Engineering or other scientific topic
- Min. 5-7 years of experience in the pharmaceutical / biotechnology industries.
- Knowledge of cGMP requirements.
- Experience in Quality Systems.
**Preferred Skills**
- Experience in IT quality systems qualification, or project management (lean six sigma) is a plus
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.
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