Sobi is looking for a Quality system manager with the ability to take SOBI´s QMS system further

Academic Resource 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 regulatory surveillance, quality risk management and quality reporting. 
den 31 maj 2019
Antal timmar
Sverige > Stockholms stad > Stockholms län

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 regulatory surveillance process and quality risk management process
• 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 NC/CAPA and change control.
• 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

• 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

Your profile
We are looking for a person with great understanding of the Quality Management System processes, who has the ability to actively search for, retrieve and draw conclusions from found information. You are driven and motivated to meet the regulatory requirements, and you have the ability to do so in an independent manner. Furthermore, you have great collaborative- and pedagogic skills, which help you educate and promote the process development within your given areas in an effective manner. 

About Sobi
Sobi™ is an international biopharmaceutical company dedicated to rare diseases. Our vision is to be recognised as a global leader in providing access to innovative treatments that transform lives for individuals with rare diseases. The product portfolio is primarily focused on treatments in Haemophilia and Specialty Care. Partnering in the development and commercialisation of products in specialty care is a key element of our strategy. Sobi has pioneered in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2017, Sobi had total revenues of SEK 6.5 billion and approximately 850 employees. The share (STO:SOBI) is listed on Nasdaq Stockholm. More information is available at www.sobi.com.

Swedish Orphan Biovitrum AB 


Skicka din ansökan

We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! Referens Sqsm0219

For more information or questions please contact:
Julia Engström 
Sebastian Forsberg 

sökord: life science gmp project management pharmaceutical biotech lean six sigma quality system engineer 

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Academic Resource
Norr Mälarstrand 100
112 35 Stockholm
Academic Resource

Julia Engström
Telefon: +46 707410680

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