Quality System Manager
Quality System Manager
Sobi
Stockholm, Sweden
We are searching for a driven and innovative Quality Assurance professional to join Sobi’s Quality Management System group within Global Quality Systems and Support. In this role you will be one of the key resources driving how Sobi works with continuous improvements of the global quality processes. You will focus primarily on being the global GxP process owner, with all what this entails, for the quality systems; Deviation, CAPA, Change Management and Validation as well as quality reporting.
As a part of the global Quality Management Systems (QMS) team you will support the fast growing global Sobi organization and help ensure that the Sobi QMS is compliant and meets the requirements set by regulatory authorities. The position is full time and you will be employed by Sobi, based in HQ in Stockholm.
Key Responsibilities:
- Lead and participate in continuous improvement of the Sobi Quality Management Systems, implementation of cGXP requirements and QMS projects to strengthen the way Sobi works
- Be the Process Owner of the Deviation, CAPA, Change Management and Validation
- Help build and monitor the effectiveness and improve the processes together with other functions, including identify and implementing relevant supporting tools to reach the next level QMS, especially related to quality processes owned by the department
- Coordinate and support the Quality reporting of KPIs, coordination and documentation of Quality Management Review (QMR) and Quality Activity Plans (QAPs).
- Support and work as back-up for GQSS team members, primarily focusing on regulatory surveillance and risk management
- Creating training material and train others in QMS related trainings when needed for processes owned by role as well as for e.g. GXP introduction trainings for new employees within the company
- Participate and support during regulatory inspections and audits of Sobi
Qualifications:
- High level education (university degree or similar) within relevant area such as biotech, pharmacy, chemistry etc.
- Relevant experience from Pharmaceutical, biotech or life science company within Quality
- Experience from implementation and/or development of quality systems and processes, preferably in an environment with GXP scope
- Technical understanding and ability to promote process improvement in quality systems
- Project management experience
- GMP related requirements
- Experience of computerized quality system and application usage
- Quality process improvement methodology, Lean/Six Sigma
- Fluently spoken and written English and Swedish
