Senior Scientific Expert, QA Support Functions 100% (m/f/d)

CSL Behring is a globally leading biotech company committed to its promise to save lives. In Bern, we develop and distribute life-saving therapies for people with severe and rare diseases worldwide with over 1800 employees.

Our team is responsible for quality oversight in the areas of quality control, ongoing stability studies, maintenance & utilities (including requalifications and revalidations), as well as warehousing and internal transport. We thereby support the manufacturing areas in ensuring the high quality of our products for our customers. This means: operational quality management in partnership with the above-mentioned organizational areas. In addition, we also support global areas for which the Manufacturing Site QA Support Functions are responsible.

Your main tasks include, among others:

• Reviewing and ensuring compliance with GMP requirements in the above-mentioned areas

• Management and approval of deviations, leading the initial risk assessment, supporting the owner of a deviation in investigating the cause, defining corrective actions, assessing the risk to products and processes, as well as the final investigation report (in German or English) of the deviation

• Management of change requests (Quality Delegate), supporting the coordinator of change requests, classifying and approving them, having quality oversight over assessments and actions of change requests and approving their closure, and switching the change requests to implementation status, participating in the global panel on change requests

• Support in quality decisions on site («Quality on the Floor») of the above-mentioned organizational areas to ensure compliance. Periodic rounds, e.g., in the warehouse area together with the operational areas

• Participates in periodic meetings of the above-mentioned operational areas to ensure timely closure of deviations, corrective actions, or GMP-relevant changes

• Supports the team in representing the area during regulatory inspections

• Technical review and approval of GMP documents of the mentioned specialist areas

• Participation in projects

• Support in optimizing systems and processes

Qualification & Professional Experience:

• Completed master's degree in natural sciences in the field of life sciences, biology, chemistry, pharmacy, or a degree in engineering or law

• Excellent knowledge of German (C2) and advanced knowledge of English (C1), written and spoken, combined with strong communication and presentation skills

• 3+ years of experience in deviation and CAPA management in a GMP environment as well as written and oral regulatory communication

• Good IT user skills

• Technical knowledge in the areas of maintenance & utilities, analytical methods, stability studies, or warehousing and logistics processes is an advantage

• An analytical mindset and the ability to quickly grasp complex contexts and present them clearly and logically structured

• High degree of independence and initiative

• Enjoyment of work and a high level of responsibility

• Team-oriented collaboration with other areas

We offer you a responsible, diverse, and exciting role within quality management. You will be an important member of the QA Support Functions team and actively support it in achieving its goals.

Do you feel addressed? Then we look forward to your online application. Your application should include a cover letter, a resume/CV as well as work certificates and copies of diplomas in the original language and/or relevant transcripts. Please combine your files, including your CV, into one document.

What we offer

We want you to feel comfortable at CSL. That is important, and so are you. Learn more about what we offer at CSL .

About CSL Behring

CSL Behring is a globally leading company that develops and distributes high-quality therapeutics for people with rare and serious diseases. With our medicines for the therapeutic areas of immunology, hematology, cardiovascular and metabolism, respiratory diseases, and transplantation medicine, we keep our promise to improve the quality of life of patients in more than 100 countries. Learn more about CSL Behring .

CSL should be as diverse as the world we live in

As a global company with employees in over 35 countries, CSL stands for diversity, fairness, and inclusion. Learn more about diversity, fairness & inclusion at CSL.

Make a difference with your work at CSL!