pEntity: CSL Behring /ppJob Category: Quality /ppJob Family: Quality Control /ppJob Type: Tempo pieno /ppLocation: Milan, Milano, Italy /ppEmployer Reference: R
- /ph3Quality Manager (m/f/x)
- EU-based /h3pLocation: Open to candidates based in countries where CSL has an affiliate presence, provided they are located within commuting distance of a CSL office and can attend the workplace in line with CSL's return-to-office policy. /ppEmployment: Full-time, Permanent /ppYou will be a key member of the Affiliate Quality Operations organization, supporting the effectiveness, compliance, and continuous improvement of CSL's Affiliate Quality Management System across Europe and global affiliates. In this role, you will partner with Quality leaders, business process owners, and stakeholders across multiple functions to ensure policies, procedures, and quality systems remain compliant, fit for purpose, and aligned with regulatory requirements and CSL standards. You will play a critical role in inspection readiness, quality system governance, process harmonization, and the implementation of global quality initiatives. This position offers the opportunity to influence quality practices across a complex international environment while collaborating with colleagues from Quality, Regulatory Affairs, Pharmacovigilance, Commercial Operations, Manufacturing, Compliance, and other business functions. /ph3The Role /h3ulliEstablish and maintain processes for reporting Quality KPIs across global affiliates. /liliCoordinate inspection readiness activities throughout the global affiliate network. /liliSupport quality management system compliance activities, ensuring policies, SOPs, work instructions, and related documentation remain current, effective, and aligned with business and regulatory requirements.



/liliManage the integration of Affiliate Quality SOPs with Global CSL procedures and facilitate procedure updates to incorporate affiliate and local requirements. /liliProvide quality support to US Commercial Operations as required. /liliSupport Product Technical Complaint (PTC) activities for the US market. /liliSupport Global Change Control, Deviation, and CAPA processes across assigned regions. /liliSupport and perform product release activities for the US market and Kankakee-manufactured export products, collaborating with manufacturing site representatives as needed. /liliLead and/or support implementation of global electronic quality systems such as SAP, Master Data Governance, and DocNet. /liliEnsure effective communication with internal and external stakeholders regarding progress, improvements, risks, and compliance-related matters. /li /ulh3Your Skills and Experience /h3ulliBachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or a related field. /liliCandidates with alternative educational backgrounds and significant relevant experience will also be considered. /liliMinimum of 2 years' experience in a pharmaceutical industry GxP-regulated role. /liliStrong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines and industry standards. /liliDemonstrated ability to work independently, take ownership of assigned projects,



and deliver results with minimal supervision. /liliExcellent interpersonal skills with the ability to build effective cross-functional relationships and work successfully within global teams. /liliStrong organizational, communication, influencing, and stakeholder management skills. /liliAbility to identify process improvement opportunities and implement practical, innovative solutions. /liliWorking knowledge of CAPA development and quality system methodologies is preferred. /liliExperience supporting or implementing electronic quality systems and digital quality tools is advantageous. /liliStrong computer skills, including Microsoft Office applications. /liliExperience with SAP, Veeva, TrackWise, SharePoint, collaboration tools, or quality databases is desirable. /liliExcellent written and verbal communication skills in English. /liliLimited travel may be required. /li /ulh3What

we offer
/h3ulliAt CSL, we are committed to improving the lives of patients around the world while providing our employees with meaningful opportunities for growth and development. /liliThis role follows CSL's hybrid working model. /liliEmployees are expected to work from a CSL office in accordance with local return-to-office requirements and team needs. /liliA collaborative, purpose-driven environment focused on innovation and quality. /liliThe opportunity to contribute to a global organization dedicated to saving and improving lives. /liliExposure to international stakeholders and diverse business functions across the CSL network. /liliProfessional development opportunities and support for continuous learning. /liliFlexible working arrangements, where applicable. /liliCompetitive compensation and benefits programs. /liliA

📌 Quality Manager (Milano)
🏢 csl
📍 Milano