Senior Quality Associate – Global Pathogen Safety

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

Innovative and committed to patients worldwide.

CSL Behring is a global biotechnology leader, driven by its promise to save lives. At our site in Bern, our employees develop and manufacture life‑saving therapies for people with serious and rare diseases around the world.

For our Global Pathogen Safety (GPS) organization in Bern, we are looking for an experienced quality professional to join us as Senior Quality Associate – Global Pathogen Safety (100%) (m/f/d).

In this role, you will provide Quality Assurance oversight for our Global Pathogen Safety laboratories and help ensure that laboratory and research activities are conducted in accordance with applicable quality and regulatory requirements. You will work closely with laboratory teams, study personnel and other stakeholders to maintain and continuously improve our quality systems, support inspection readiness and foster a strong and proactive quality culture.

Your primary focus will be on compliance with the OECD Principles of Good Laboratory Practice (GLP), GCLP (ISO/IEC 17025) and CSL's Good Research Laboratory Practice (GRLP) standards. Depending on business needs, you may also provide quality oversight for nonclinical development activities within Research EU and support biosecurity and biosafety compliance at the Bern site.

Responsibilities

• Provide Quality Assurance oversight for Global Pathogen Safety laboratory activities and ensure compliance with applicable GLP, GCLP/ISO 17025, GRLP and internal CSL requirements.
• Establish, maintain and continuously improve quality procedures, standards and systems in collaboration with laboratory teams and other stakeholders.
• Review study plans, protocols and reports for GLP compliance and prepare Quality Assurance statements for final study reports.
• Plan and conduct process, facility, study and document inspections in accordance with GLP and GRLP requirements, document findings and follow up on resulting actions.
• Communicate inspection results and quality-related observations to Facility Management, Study Directors, Principal Investigators and other relevant stakeholders.
• Support inspection readiness and participate in or host regulatory inspections, providing guidance and support for responses and resulting quality actions.
• Support the internal audit and inspection program and contribute to the timely and compliant implementation of corrective and preventive actions (CAPAs).
• Act as a Quality Assurance partner for laboratory teams and other functions, providing guidance on quality systems, compliance requirements and continuous improvement opportunities.
• Support biosecurity and biosafety compliance for CSL operations in Bern in accordance with applicable global, regional and local requirements, as required.
• Collaborate with colleagues across the global laboratory network to support harmonized quality standards, processes and continuous improvement initiatives.
• Depending on business needs, provide Quality Assurance oversight for nonclinical development activities within Research EU.

Qualifications

• Bachelor's degree in Biology, Microbiology, Life Sciences or another relevant scientific discipline.
• At least 3 years of professional experience in Quality Assurance, R&D, laboratory operations or another relevant regulated environment.
• Practical knowledge and understanding of the OECD Principles of Good Laboratory Practice (GLP) and their application within laboratory or research environments.
• Experience with Quality Management Systems and the implementation, maintenance or continuous improvement of quality processes.
• Experience in R&D Quality Assurance, process development or similarly regulated laboratory environments is highly desirable.
• Knowledge of microbiology, pathogen safety, biological containment and/or applicable biosafety and biosecurity requirements is an advantage.
• Experience with laboratory inspections, audits, CAPAs or regulatory inspections is highly desirable.
• Strong planning and organizational skills with the ability to manage multiple priorities independently.
• Strong communication and stakeholder management skills, with the ability to communicate quality and compliance requirements clearly across different functions and levels of the organization.
• Sound judgment, analytical thinking and confident decision‑making skills combined with a pragmatic and solution-oriented approach.
• Proactive mindset and commitment to continuous improvement, collaboration and a strong quality culture.

About this position

• As a Senior Quality Associate within Global Pathogen Safety, you will work at the interface of science, laboratory operations and Quality Assurance.
• The position combines hands-on quality oversight with inspections, quality systems, regulatory compliance and cross-functional collaboration, giving you exposure to a broad range of laboratory and research activities.
• You will collaborate with stakeholders in Bern as well as colleagues across our global network and have the opportunity to contribute to the continuous development and harmonization of quality processes within Global Pathogen Safety.
• Your work will directly support robust scientific practices, regulatory compliance and the consistent application of CSL quality standards.