Senior Quality Associate – Global Pathogen Safety

About the role

CSL Behring, a global biotechnology company developing and manufacturing therapies for serious and rare diseases, is hiring a Senior Quality Associate (100%, m/f/d) for its Global Pathogen Safety (GPS) organization in Bern. The role provides Quality Assurance oversight for GPS laboratories so that laboratory and research activities comply with quality and regulatory requirements. It works closely with laboratory teams, study personnel and other stakeholders to maintain and improve quality systems, support inspection readiness and foster a proactive quality culture.

Key responsibilities

• Provide QA oversight for Global Pathogen Safety laboratory activities and ensure compliance with GLP, GCLP/ISO 17025, GRLP and internal CSL requirements.
• Establish, maintain and improve quality procedures, standards and systems with laboratory teams and stakeholders.
• Review study plans, protocols and reports for GLP compliance and prepare QA statements for final study reports.
• Plan and conduct process, facility, study and document inspections, document findings and follow up on actions.
• Communicate inspection results and quality observations to Facility Management, Study Directors and Principal Investigators.
• Support inspection readiness, participate in or host regulatory inspections and guide responses and quality actions.
• Support the internal audit and inspection program and contribute to timely, compliant CAPA implementation.
• Act as a QA partner for laboratory teams, and support biosecurity and biosafety compliance at the Bern site.
• Collaborate with colleagues across the global laboratory network; depending on business needs, also oversee nonclinical development activities within Research EU.

Required profile

• Bachelor's degree in Biology, Microbiology, Life Sciences or another relevant scientific discipline.
• At least 3 years of professional experience in QA, R&D, laboratory operations or another regulated environment.
• Very good German and English, written and spoken.

Required skills

• Practical knowledge of the OECD GLP principles and their application in laboratory or research settings.
• Experience with Quality Management Systems and continuous improvement of quality processes.
• Experience in R&D QA, process development or similar regulated laboratory environments is highly desirable.
• Knowledge of microbiology, pathogen safety, biological containment and biosafety/biosecurity requirements is an advantage.
• Experience with laboratory inspections, audits, CAPAs or regulatory inspections is highly desirable.
• Strong planning, organizational, communication and stakeholder management skills.