Senior Manager, QA Release
Senior Manager, QA Release
CSL Behring is a leading global biotherapeutics company committed to its promise to save lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.
In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies.
The CSL Behring Recombinant Facility (RCF) in Lengnau is part of CSL's ongoing global expansion strategy to support the company's long-term growth plans.
The new plant in Lengnau will manufacture three recombinant coagulation factors to treat hemophilia A & B patients. Two of these productshave already received marketing approval and have been successfully launched. The Lengnau site project requires an investment of several hundred millions USD and will create around 300 new jobs when it is fully operational in 2019/2020.
Are you interested in being part of this exciting project?
We are looking for an experienced
This position requires an experienced Quality Assurance Expert with a scientific education having worked for a minimum of 7 years in the Quality Assurance product release of a biotech company or in aseptic filling within the pharmaceutical industry. During the period of establishing the new manufacturing site the position holder will be part of the facility program and implement the necessary systems within the facility. In particular the position holder will be involved to design and establish procedures necessary for QA batch release and to create the electronic batch record system for the facility.
The position holder acts as delegate of the Qualified Person for the QA review, the compliance check and the technical as well as market release (Switzerland) of recombinant coagulation factors for product launch and supplies as necessary.
Main Responsibilities and Accountabilities:
Delegate of the Fachtechnisch Verantwortliche Person (FvP) / Qualified Person:
Acts within the assigned batch record review and batch release responsibilities as delegate of the Fachtechnisch Verantwortliche Person (FvP)
Establishes an operational QA Release team of the CSL Behring Recombinant Facility AG site.
During the project phase creates the operational elements such as SOPs, form sheets, log books and others to establish QA batch review and release functions for the site.
Establishes in collaboration with the automation and production team the electronic batch record for drug substance production (up- and downstream) as well as filling and packaging operations.
Ensures the successful participation of the QA Release Team during health authority inspections.
In the operational set up of the plant executes with his/her team QA review and approval of master batch records, the QA Batch record review for marketed products and the QA release including certification (technical and market) for drug substance, bulk product and finished product batches. Preparation and attendance to health authority inspection within the area of responsibilities.
Qualifications & Experience:
We are looking for an experienced Chemist / Biologist / Microbiologist / Biochemist or Immunologist with minimum of 7 years' experience in leading a QA team performing batch review / release functions of the biotech / pharmaceutical industry.
Knowledge of pharmaceutical manufacturing in particularly of biotechnological drug substance manufacturing would be an asset.
Are you motivated to join us in this exciting journey to establish a state of the art pharma manufacturing facility with most advanced technologies?
Offices will be in Stöckacker, Bern, and later in Lengnau.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. For initial information you are welcome to contact Recruitment at +41 31 344 12 51.
Worker Sub Type: