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.

About CSL Plasma

CSL Plasma operates one of the world’s largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.