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Associate director, quality assurance support

Bern
CSL
Inserat online seit: 24 April
Beschreibung

CSL 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 deviatio

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