Stellenbeschreibung

For our location in Bern, we are looking for a

Quality Manager (ECI Region)

The purpose of this position is to be responsible for quality management related activities to ensure compliance within the area of responsibility with internal policies/ procedures and local regulations. Currently about 40 active markets.

Main Responsibilities and Accountabilities:

• Facilitates all necessary processes with all involved internal functions and external partners to ensure CSL products are reaching the distributor markets in full compliance with relevant quality standards.


• Coordination of Change Requests.


• Coordinate Pharmaceutical Technical Complaint (PTC) handling and temperature deviations.


• Ensure and organize that the appropriately reviewed and signed Quality Agreements and Confidential Agreements are in place with each collaboration party (e.g. distributor).


• Responsible for training of external personnel in Quality relevant matters (e.g. PTC handling, temperature deviations etc.).


• Provide support to quality audits.


• Responsible for compliance with reporting deadlines for deviations/complaints reporting as laid down in relevant SOPs /policies and regulations.


• Coordination of quality deviations in ECI (participation in Quality deviation Meetings and discussions)


• Develop Quality procedural documentation (SOPs) in accordance with CSL policies and procedures.


• Writing and reviewing quality SOP and working instructions.


• Support new established affiliates, branches or rep. offices in quality matters


• Support the selection of qualified Quality staff at the distributor/agent. Ensure appropriate, relevant and timely training of Quality functions on adherence to all applicable CSL Behring policies/ procedures and guidelines.

Qualifications & Experience:

• Minimum Master Degree in life-sciences (pharmacy, chemistry, biochemistry), PhD preferable.


• Fluency to negotiate in English and German.


• At least 3 years of professional working experience in Quality Management in a multinational innovative pharmaceutical company.


• Knowledge in current European regulatory and GMP legislations and guidelines; Understanding of regulatory & quality system.


• Project management experience in a matrix structure.

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.