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

• 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
  

• 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
  

• 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
  

• 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