Senior Quality Associate x2

The Opportunity # The Senior Quality Associate ensures that internal operations across Global Pathogen Safety (GPS) laboratories in Bern are conducted in compliance with the OECD Principles of Good Laboratory Practice (GLP), GCLP (ISO/IEC 17025), and Good Research Laboratory Practice. The role may be required to support biosecurity and biosafety to CSL operations in Bern in alignment with relevant global, regional, and country-specific regulations, as well as CSL internal policies and procedures. It supports the implementation and improvement of GLP/GCLP/GRLP-aligned quality systems and processes across laboratory networks, advancing global quality strategies for GPS activities. Additionally, this position may be required to provide quality oversight for nonclinical development activities in Research EU and collaborate globally to ensure consistent CSL quality standards.   This position supports inspection readiness, audits, and regulatory interactions, helping ensure timely and compliant completion of quality actions, such as corrective and preventive actions (CAPAs). In addition, the Senior Quality Associate models the CSL Way and fosters a strong, proactive quality culture, driving sustainable improvements in quality systems, processes, and cross-site collaboration. Your Tasks & Responsibilities # • Establish procedures, standards, and systems to meet local and regulatory requirements with stakeholders. • Liaise with stakeholder departments regarding quality assurance and compliance related issues • Maintain documentation in line with OECD principles of GLP, ISO 17025 standards and internal CSL standard - Good Research Laboratory Practice (GRLP) • Review and approve study plans, protocols, and reports for GLP compliance; prepare QA statements for final reports. • Plan and conduct inspections (GLP/GRLP process, facility, study, document) to ensure compliance and report findings and recommendations. • Report inspection results to Facility Management, Study Director, and Principal Investigator as needed. • Advise CSL facility owners and project managers on biosecurity and biosafety compliance (as required) • Ensure inspection readiness; host/participate in regulatory agency inspections and provide support, direction and guidance relating to responses • Support internal audit program and perform internal inspections per guidelines. • Ensure CSL facilities comply with all biosafety, biosecurity, and regional regulatory requirements. Your Skills and Experience # Education • BS degree in relevant biological science, science, or related discipline Experience • Minimum 3 years- experience working in at least one of the following: OGTR, Department of Agriculture, applicable EU Directives, and/or similarly governed laboratories • R&D Quality Assurance or relevant process development facilities • Understanding and application of standards for microbiology and pathogen safety and containment • Knowledge of OECD Principles of GLP • Experience and knowledge in the application of Quality Systems Competencies • Commitment to improvement • Strong planning and organizational skills • Good presentation, negotiation, and decision-making skills • Strong customer focus CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.