Job Detail

Stellenbeschreibung

Innovative and committed to patients around the world.

Leading-edge medicines made in Bern.

CSL Behring – the global biotherapeutics provider driven by its promise to save lives.

In Bern, we employ more than 1,400 people dedicated to developing and distributing life-saving therapies indicated for the treatment of rare and serious conditions.

CSL is a subsidiary of CSL Limited, headquartered in Melbourne, Australia.

Director Vendor Quality

As a successful Director Vendor Quality you provide a strategic, holistic Quality oversight of all outsourced GxP relevant services used for global Research and Development (R&D). This includes an oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.

Like this, you are the global central point of contact and lead for R&D business functions and vendor Quality units regarding quality and compliance.

Your responsibilities in detail include:

• Proactive evaluation, monitoring, reporting and escalation of the Quality system in accordance with the R&D Quality System


• Establishment of an end-to-end view and a clear direction of the quality management for R&D service providers including vendor assessment, qualification, risk-based monitoring, compliance trending and reporting, Quality Agreements and Quality Assurance for the global Health Authority regulations and data integrity


• Successfully interfacing with business functions such as Pharmacovigilance, Clinical Development, Research, Product Development, Regulatory Affairs, Early Development, Commercial Development, Commercial Operations (Affiliates), Global Quality and Medical Affairs


• Supporting Global Quality partners to implement and continuously improve the Quality business processes in accordance with the Enterprise Process Management excellence models in relation to Vendor Quality Management


• Providing oversight of CAPA execution in conjunction with auditing groups


• Development, codifying and implementation of a risk-based Quality Agreement program for R&D vendors


• Continuous assessment, in conjunction with R&D Quality SMEs, GxP-related compliance inquiries from R&D business functions and continuous alignment and consistency within R&D Quality on vendor management principles

As a self-starter, you appreciate growth and development in your environment, you are a leader, who manages his stakeholders always on an eye-to-eye-level and inspire others through your competencies as well as your clear direction?

Furthermore, you possess the following competencies:

• University degree in a scientific, medical or pharmaceutical discipline


• Extensive understanding of the drug development lifecycle from drug discovery through Pharmacovigilance


• Ten years of professional work experience in Biopharmaceuticals, with responsibility in quality management of external and outsourced services


• Thorough knowledge of applicable GxP regulations


• Effective communication, collaboration and negotiating skills


• Experience in project management, especially related to process improvement


• Strong ability to work in a global growing matrix organization