Quality System Manager for the pharmaceutical company Sobi
Academic Resource are now searching for a Quality System Manager for a position at Sobi. In this role you will work specifically with focus on QMS regulatory surveillance, quality risk management and quality reporting. As a part of the team you will support the organization and help ensure that the Sobi quality systems is compliant and meets the requirements set by regulatory authorities. In this role you will be a part of the Global Quality System and Support team and the position will be based in HQ in Stockholm. The position is full time and you will be employed by Sobi.
In this position you will be responsible for QMS regulatory surveillance process including creating an improved process for Sobi as well as supporting the organization, monitoring the effectiveness of the process and supporting tool. You will also train user in the process. You will support implementation of current requirements, standards and continuous improvement related to QMS for QMS owned by department.
•Participate in the development, maintaining and reporting of the QMS, and help build and improve the Sobi QMS to reach the next level QMS, especially related to quality processes owned by the GQSS department
•Lead and participate in cGXP continuous improvement and QMS improvement project to strengthen the Quality System
•Be the process owner of the regulatory surveillance process and quality risk management process
•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 working with 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
•Lead and participate in continuous improvement and QMS improvement project
•Participate and support during regulatory inspections and audits of Sobi
•High level education (university degree or similar)
•Experience from Pharmaceutical, biotech or life science company for minimum of 3 years
•Minimum 3-8 years work experience
•Implementation of quality systems and processes , preferably in an environment with GXP scope
•Experience of computerized quality system and application usage •GMP related requirements
•Fluently spoken and written English and Swedish
•Technical understanding and ability to promote process improvement quality systems
•Project management •Quality process improvement methodology, Lean/Six Sigma
•Good collaboration skills
•Good communication skills
•Proven ability to work independently
•Ability to actively search for, retrieve and draw conclusions from found information
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 www.sobi.com
We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! Referens Sqsm0219
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