Associate Director, Quality Assurance Support

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 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-making

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.

Was wir bieten

Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten .

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 Behring .

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 Vielfalt, Fairness & Inklusion bei CSL.

Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!