Senior Quality Associate - Global Pathogen Safety QA Lead

CSL; Bern; On-site; CHF 110,000 - 140,000; Full time

Job summary

CSL Behring in Bern, part of Global Pathogen Safety (GPS), seeks an experienced Senior Quality Associate to oversee quality assurance for GLP, GRLP and ISO 17025 aligned activities. You will collaborate with laboratory teams, study personnel and stakeholders to strengthen quality systems and inspection readiness.

You will support regulatory inspections, CAPA processes and continuous improvement across CSL operations in Bern, contributing to robust scientific practices and biosafety compliance

Qualifications

• Bachelor's degree in Biology, Microbiology, Life Sciences or related field.
• Minimum 3 years in Quality Assurance, R&D, lab operations or regulated environment.
• Hands-on knowledge of OECD GLP principles and their applications.
• Experience with Quality Management Systems and continuous improvement.
• Desirable experience in R&D QA or regulated lab environments.
• Knowledge of biosafety and biosecurity requirements is a plus.
• Experience with inspections, audits, CAPAs or regulatory inspections is desirable.
• Strong planning, organizational and communication skills.

Responsibilities

• Provide QA oversight for GLP, GCLP/ISO 17025, GRLP and CSL requirements.
• Develop and improve quality procedures, standards and systems with lab teams.
• Review study plans, protocols and reports for GLP compliance.
• Plan and conduct inspections and follow up on corrective actions.
• Communicate inspection results and quality observations to stakeholders.
• Support inspection readiness and regulatory inspections; assist responses.
• Support CAPA implementation in a timely, compliant manner.
• Act as QA partner across functions to drive continuous improvement.
• Support biosecurity and biosafety compliance across Bern operations.

Skills

Quality Assurance

GLP

Regulatory inspections

Stakeholder management

Inspection readiness

Education

Bachelor's degree in Biology or Life Sciences

Job description

CSL Behring in Bern, part of Global Pathogen Safety (GPS), seeks an experienced Senior Quality Associate to oversee quality assurance for GLP, GRLP and ISO 17025 aligned activities. You will collaborate with laboratory teams, study personnel and stakeholders to strengthen quality systems and inspection readiness.

You will support regulatory inspections, CAPA processes and continuous improvement across CSL operations in Bern, contributing to robust scientific practices and biosafety compliance