Senior Quality Associate – Global Pathogen Safety

About the role

CSL Behring seeks an experienced quality professional to provide Quality Assurance oversight for Global Pathogen Safety laboratories in Bern. The role ensures laboratory activities comply with GLP, GCLP/ISO 17025 and internal standards, supporting inspection readiness and a proactive quality culture.

Key responsibilities

• Provide QA oversight for laboratory activities, ensuring compliance with GLP, GCLP/ISO 17025, GRLP and internal CSL requirements.
• Establish, maintain and improve quality procedures, standards and systems in collaboration with laboratory teams.
• Review study plans, protocols and reports for GLP compliance and prepare QA statements for final reports.
• Plan and conduct inspections, document findings and follow up on corrective actions.
• Support inspection readiness, host regulatory inspections and assist with CAPA implementation.

Required profile

• Bachelor's degree in Biology, Microbiology, Life Sciences or related discipline.
• At least 3 years of experience in Quality Assurance, R&D, laboratory operations or a regulated environment.
• Practical knowledge of OECD GLP principles and their application in laboratory settings.
• Strong planning, organizational and stakeholder communication skills.

Required skills

• Good Laboratory Practice (GLP) compliance
• GCLP / ISO/IEC 17025 standards
• Quality Management Systems implementation
• CAPA and audit processes