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.