Xbrane is an innovative company developing Biosimilar products. Xbrane together with STADA just launched the first biosimilar product on the European market. By joining Xbrane, you will be part of a biopharmaceutical drug development company with the goal to ensure the access of biologics to an underserved patient population, enabling global health equality. Xbrane keeps on growing and is now seeking for an experienced QA to take on the role as QP in the quality team.
The Role
As Qualified Person (QP), you will work closely with the QA team supporting quality oversight of Xbrane CMOs. You will also coordinate and contribute as an expert in the upcoming submission for a manufacturing license, with the long-term goal to independently release biosimilar products to the market. You will also ensure, together with Xbrane team and management, that the internal quality management system (QMS) complies with regulations and requirements from authorities. In addition, you will also be responsible of ensuring that partners and contract organizations are in compliance with the quality agreements.
The role includes responsibilities such as:
- Participate as QP in general in quality work and in various projects
- Lead the development and improvement of the quality system (QMS)
- Together with the QA team represent the company in customer and authority inspections as well as internal inspections
- Quality expert support in complex deviation management and CAPA
Xbrane's manufacturing and supply chain are located at various CMOs in Europe, USA and the UK. So you need to be skilled with working in external collaborations in a global setting. You will join a diverse team in an entrepreneurial workplace with many different contacts.
Your Profile
To succeed in this role, you are confident and knowledgeable in GMP, are a natural leader and enjoy creating collaborations both internally and externally and have a humble but confident mindset. You are used to working in projects and have a coaching way in educating and ensure quality compliance in the organization.
In addition, you need the following qualifications:
- Minimum Bachelor’s degree in natural sciences, such as a Pharmacist, Microbiologist, Biotechnologist, Chemist, Biologist, Engineer or similar
- Several years of work experience in the pharma industry whereof some from Biologics
- Fulfills the requirements for QP, LVFS 2004:7
- Experience of working as QP
- Very good knowledge of GMP and its application
- Preferably fluent in Swedish and English, as both documentations and meetings occur in both languages.
