Senior Quality Associate – Global Pathogen Safety

ppbInnovative and committed to patients worldwide. /b 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. /p pFor our bGlobal Pathogen Safety (GPS) /b organization in Bern, we are looking for an experienced quality professional to join us as /p h3Senior Quality Associate – Global Pathogen Safety (100%) (m/f/d) /h3 pIn 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. /p pYour primary focus will be on compliance with the bOECD Principles of Good Laboratory Practice (GLP), GCLP (ISO/IEC 17025) and CSL's Good Research Laboratory Practice (GRLP) /b 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. /p h3Responsibilities /h3 ul liProvide Quality Assurance oversight for Global Pathogen Safety laboratory activities and ensure compliance with applicable GLP, GCLP/ISO 17025, GRLP and internal CSL requirements. /li liEstablish, maintain and continuously improve quality procedures, standards and systems in collaboration with laboratory teams and other stakeholders. /li liReview study plans, protocols and reports for GLP compliance and prepare Quality Assurance statements for final study reports. /li liPlan and conduct process, facility, study and document inspections in accordance with GLP and GRLP requirements, document findings and follow up on resulting actions. /li liCommunicate inspection results and quality-related observations to Facility Management, Study Directors, Principal Investigators and other relevant stakeholders. /li liSupport inspection readiness and participate in or host regulatory inspections, providing guidance and support for responses and resulting quality actions. /li liSupport the internal audit and inspection program and contribute to the timely and compliant implementation of corrective and preventive actions (CAPAs). /li liAct as a Quality Assurance partner for laboratory teams and other functions, providing guidance on quality systems, compliance requirements and continuous improvement opportunities. /li liSupport biosecurity and biosafety compliance for CSL operations in Bern in accordance with applicable global, regional and local requirements, as required. /li liCollaborate with colleagues across the global laboratory network to support harmonized quality standards, processes and continuous improvement initiatives. /li liDepending on business needs, provide Quality Assurance oversight for nonclinical development activities within Research EU. /li /ul h3Qualifications /h3 ul liBachelor's degree in Biology, Microbiology, Life Sciences or another relevant scientific discipline. /li liAt least 3 years of professional experience in Quality Assurance, RD, laboratory operations or another relevant regulated environment. /li liPractical knowledge and understanding of the OECD Principles of Good Laboratory Practice (GLP) and their application within laboratory or research environments. /li liExperience with Quality Management Systems and the implementation, maintenance or continuous improvement of quality processes. /li liExperience in RD Quality Assurance, process development or similarly regulated laboratory environments is highly desirable. /li liKnowledge of microbiology, pathogen safety, biological containment and/or applicable biosafety and biosecurity requirements is an advantage. /li liExperience with laboratory inspections, audits, CAPAs or regulatory inspections is highly desirable. /li liStrong planning and organizational skills with the ability to manage multiple priorities independently. /li liStrong communication and stakeholder management skills, with the ability to communicate quality and compliance requirements clearly across different functions and levels of the organization. /li liSound judgment, analytical thinking and confident decision-making skills combined with a pragmatic and solution-oriented approach. /li liProactive mindset and commitment to continuous improvement, collaboration and a strong quality culture. /li /ul h3About This Position /h3 ul liAs a Senior Quality Associate within Global Pathogen Safety, you will work at the interface of science, laboratory operations and Quality Assurance. /li liThe 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. /li liYou 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. /li liYour work will directly support robust scientific practices, regulatory compliance and the consistent application of CSL quality standards. /li /ul /p #J-18808-Ljbffr