Sr Mgr, Quality Assurance Systems

CSL Behring Lengnau AG (Lengnau BE, Schweiz) Vor 2 Tagen veröffentlicht

With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat people with life-threatening medical conditions and to help them live full 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. In May 2020, CSL announced the strategic partnership with Thermo Fisher Scientific, the world leader in serving science. Thermo Fisher will lease and operate the Lengnau state-of-the-art biotech manufacturing facility once construction is completed in 2021. It is anticipated that employees at the site who are engaged for the operation of the site and the commercial production of our therapies in Lengnau will automatically transfer to Thermo Fisher Scientific once construction is complete.  Today, more than 200 employees work in Lengnau.

You can find more information on the strategic partnership with Thermo Fisher here and some more information about the prospects of a future career with Thermo Fisher here.

We are looking for talented and dedicated personalities that share our passion to develop and deliver innovative therapies. With your commitment, reliability and high-quality standards, you help us to improve the quality of life for those in need.

We are currently recruiting for a

Sr. Manager, Quality Assurance Systems

Responsibilities:

  • The role provides leadership and execution of all Quality Assurance Systems related activities for the Lengnau site with a team of 5 – 10 associates.
  • During the period of establishing the new manufacturing site the position holder will be part of the Lengnau program and implement the necessary quality system elements to operate Quality Assurance Systems function tasks:
    • Document Management,
    • Training Management,
    • Change Control,
    • Deviation Handling,
    • GMP governance (Continuous Improvement, Quality Management Review, etc.),
    • Supplier Qualification and incl. Quality Agreements,
    • Quality Risk Management, and
    • Audit and Inspection Management on behalf of the “Fachtechnisch Verantwortliche Person”.
  • This position requires an experienced quality assurance manager with significant experience in working within quality assurance systems as well as improving / establishing quality assurance systems for the pharmaceutical / biotech industry.
  • Experience in the establishment of new electronic quality assurance tools is an asset:
    • Document Management for all GMP relevant documents
    • Training Management for Lengnau facility
    • Trackwise platforms for Change Control, Deviation and CAPA Handling and
    • Audit/Inspection Management for Lengnau facility.

Qualifications:

  • Degree (Masters or higher) in Pharmacy or Life Sciences (Biology, Chemistry, etc.).
  • Demonstrated strong understanding of the pharmaceutical sector and / or cGMP.
  • Demonstrated knowledge of regulations such as CFR, PiC/S, EudraLex, lCH, USP.
  • Experienced in leading a team.
  • Significant project management skills with the ability to communicate and collaborate with multiple stakeholders.
  • Familiar with the various Quality Assurance Systems including: Risk Management, Continuous lmprovement, Management Awareness, Audit & lnspections, Change Control, Deviation Handling and CAPA.

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.

CSL Behring is committed to provide equal employment opportunity for all.

Worker Type:

Employee

Worker Sub Type:

Regular
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Sr Mgr, Quality Assurance Systems

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