CSL Behring, a subsidiary of the Australian company CSL Limited, is a worldwide biopharmaceutical company operating manufacturing plants on several continents.
In May 2014, CSL selected Lengnau (Canton Bern) as the location of a new manufacturing facility for the 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 is currently under construction and will manufacture three recombinant coagulation factors to treat hemophilia A & B patients.
To establish the site's future QA release organization responsible for drug substance production, aseptic filling and packaging operations we are looking for an experienced
Director, QA Release
being enthusiastic about creation of a lasting footprint within the new site. Over the next years the focus for this position will be the establishment of the QA review and release systems, the master batch record creation for the various operations and the set up of the QA release organization.
Main Responsibilities and Accountabilities:
Leads the establishment of a performing, data driven QA release organization being capable to support the different operations on the site
Ensures during the project phase the establishment of state of the art electronic batch records for a fully paperless facility
Leads the design of lean QA review systems using electronic solutions by applying review by exception principles
Once the facility is operational, manages all activities related to QA batch record review and release according to CSL Behring Recombinant Facility AG licenses.
Is responsible to manage and execute the transfer of QA operational activities from external manufacturing operations to Lengnau.
Requires a university degree in chemistry, biochemistry, biology or pharmaceutical sciences or related field An advanced degree is an asset
Proven track record in personnel management of a bigger team
Very good command of German and English
Minimum of 5 to 7 years working experience leading a QA release team of a pharmaceutical or biotechnical manufacturing site. Several years of experience in a QA function of an aseptic manufacturing plant is a requirement. Additional knowledge of pharmaceutical QC testing is an asset.
Proven QA team leader having the ability to inspire and motivate teams. Excellent communication, organizational and interpersonal skills.
Are you interested? 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. Please include all these in one document together with the CV.
Offices will be in Stöckacker Bern and later in Lengnau.