Associate Director, Quality Assurance Support page is loaded## Associate Director, Quality Assurance Supportlocations: EMEA, CH, Kanton Bern, Bern, CSL Behringtime type: Vollzeitposted on: Heute ausgeschriebenjob requisition id: R-264596CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern, more than 1500 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.For our location in Bern, we are currently looking for a# # # **Associate Director, Quality Assurance Support**## **Responsibilities*** Responsible for routine and non-routine quality oversight activities in collaboration with local operational units (Maintenance & Utilities, Quality Control, warehouse & internal transport) and qualification activities in Opex and periodic re-qualification projects* Ensures operational quality management according to cGMP to guarantee appropriate service quality for Value Streams and compliance with CSL standards and procedures* Reviews and approves complex GxP records and documentation* Supports and approves complex quality risk assessments, non-conformances, investigations, CAPAs, and change controls* Monitors relevant quality performance metrics and drives improvement initiatives* Leads project management and implementation of complex cross-functional and global projects* Acts as Subject Matter Expert (SME) for complex deviations and changes during inspections and audits; collaborates with global QA Support Functions### ## ## ## **Quality Oversight & Stakeholder Collaboration*** Ensures proactive QA oversight and drives quality decisions with stakeholders across maintenance/utilities, utility monitoring, material management, warehousing, and QC* Conducts periodic warehouse floor tours with warehouse supervision and Supply Chain teams to address improvements, exceptions, and material usage decisions* Initiates and supports implementation of new “Quality on the Floor” activities### ## ## ## **Deviation, Change & Document Handling*** Independently manages complex and cross-functional deviations at local and cross-site level* Performs “Quality Delegate” function for change management* Reviews and provides QA approval for GxP documentation within assigned areas### ## ## ## **Additional Responsibilities*** Reviews and completes APR/PQR raw material data* Leads cross-functional Tier 1 meetings (QC, warehouse, M2U)* Coordinates and delivers GMP training and qualification of new employees in QA Support Functions* Independently prepares and presents quality investigations and changes to health authorities**Qualification*** **8+ years of experience** in a similar role with a high degree of independence and strong self-directed learning capabilities* cGMP and Compliance* Engineering & maintenance operations* Utility monitoring programs* Material management, warehousing & logistics* Quality control & analytical methods* Change control management* Deviation management* CAPA management* **Strong collaboration skills** with proven ability to build cross-functional networks and drive efficient interfaces between departments* **Coaching & mentoring skills** with the ability to upskill colleagues in areas of expertise* **Excellent communication abilities**, capable of explaining complex technical matters in a clear, concise and precise manner* **Strong influencing and presentation skills**, enabling effective stakeholder engagement and decision-makingWe 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.## **Was wir bieten**Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, .## **Über CSL Behring**CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über .## **CSL soll so vielfältig sein wie die Welt, in der wir leben**Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über bei CSL.## **Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!**
#J-18808-Ljbffr