Senior QA Specialist, Global Pathogen Safety GLP Compliance

CSL Vifor; Bern; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

CSL Behring Bern is seeking an experienced Senior Quality Associate within Global Pathogen Safety to provide QA oversight for GLP/GCLP (ISO 17025) and GRLP, ensuring laboratory and research activities meet quality and regulatory requirements.

You will collaborate with lab teams, study personnel and stakeholders to maintain, improve quality systems and inspection readiness, support regulatory inspections, CAPAs and biosafety compliance at the Bern site, and align with CSL's global quality

Qualifikationen

• Bachelor's degree in Biology, Microbiology, Life Sciences or related field.
• At least 3 years of QA, R&D, or regulated lab experience.
• Familiar with GLP, GCLP/ISO 17025 and GRLP standards.
• Experience with QAMS and CAPA processes.

Aufgaben

• Provide QA oversight for GLP, GCLP/ISO 17025, GRLP and CSL requirements.
• Develop and improve quality procedures and systems with lab teams.
• Review study plans, protocols and reports for GLP compliance.
• Plan and conduct inspections per GLP/GRLP; document findings and actions.
• Report inspection results to Facility Management, Study Directors, PIs.
• Support inspection readiness and regulatory inspections.
• Support internal audits and CAPA implementation.
• Serve as QA partner for lab teams, guiding quality systems.
• Assist biosecurity and biosafety compliance at Bern site.
• Collaborate with CSL global lab network to harmonize standards.
• Provide QA oversight for nonclinical development activities as needed.

Kenntnisse

GLP knowledge

Quality Assurance

Regulatory inspections

Quality Management Systems

Stakeholder management

Ausbildung

Bachelor's degree in Biology, Microbiology, Life Sciences

Jobbeschreibung

CSL Behring Bern is seeking an experienced Senior Quality Associate within Global Pathogen Safety to provide QA oversight for GLP/GCLP (ISO 17025) and GRLP, ensuring laboratory and research activities meet quality and regulatory requirements.

You will collaborate with lab teams, study personnel and stakeholders to maintain, improve quality systems and inspection readiness, support regulatory inspections, CAPAs and biosafety compliance at the Bern site, and align with CSL's global quality