ph3Global Quality Manager (m/f/x) - EU-based /h3 pbEmployment: /b Full-time, Permanent /p pYou 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.
/p pIn 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.
/p pThis 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.
/p h3The Role: /h3 pReporting to the Affiliate Quality Head, US Quality Systems, Standards Governance, you will: /p ul liEstablish and maintain processes for reporting Quality KPIs across global affiliates.
/li liCoordinate inspection readiness activities throughout the global affiliate network.
/li liSupport quality management system compliance activities, ensuring policies, SOPs, work instructions, and related documentation remain current, effective, and aligned with business and regulatory requirements.
/li liManage the integration of Affiliate Quality SOPs with Global CSL procedures and facilitate procedure updates to incorporate affiliate and local requirements.
/li liProvide quality support to US Commercial Operations as required.
/li liSupport Product Technical Complaint (PTC) activities for the US market.
/li liSupport Global Change Control, Deviation, and CAPA processes across assigned regions.
/li liSupport and perform product release activities for the US market and Kankakee-manufactured export products, collaborating with manufacturing site representatives as needed.
/li liLead and/or support implementation of global electronic quality systems such as SAP, Master Data Governance, and DocNet.
/li liEnsure effective communication with internal and external stakeholders regarding progress, improvements, risks, and compliance-related matters.
/li /ul h3Your Skills and Experience: /h3 ul liBachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or a related field.
Candidates with alternative educational backgrounds and significant relevant experience will also be considered.
/li liMinimum of 2 years' experience in a pharmaceutical industry GxP-regulated role.
/li liStrong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines and industry standards.
/li liDemonstrated ability to work independently, take ownership of assigned projects, and deliver results with minimal supervision.
/li liExcellent interpersonal skills with the ability to build effective cross-functional relationships and work successfully within global teams.
/li liStrong organizational, communication, influencing, and stakeholder management skills.
/li liAbility to identify process improvement opportunities and implement practical, innovative solutions.
/li liWorking knowledge of CAPA development and quality system methodologies is preferred.
/li liExperience supporting or implementing electronic quality systems and digital quality tools is advantageous.
/li liStrong computer skills, including Microsoft Office applications.
Experience with SAP, Veeva, TrackWise, SharePoint, collaboration tools, or quality databases is desirable.
/li liExcellent written and verbal communication skills in English.
/li liLimited travel may be required.
/li /ul h3What we offer: /h3 pAt CSL, we are committed to improving the lives of patients around the world while providing our employees with meaningful opportunities for growth and development.
We offer: /p ul liA collaborative, purpose-driven environment focused on innovation and quality.
/li liThe opportunity to contribute to a global organization dedicated to saving and improving lives.
/li liExposure to international stakeholders and diverse business functions across the CSL network.
/li liProfessional development opportunities and support for continuous learning.
/li liFlexible working arrangements, where applicable.
/li liCompetitive compensation and benefits programs.
/li liA culture that values inclusion, integrity, accountability, and high performance.
/li libCompensation: /b Salary ranges for this role differ by country and are aligned with local market conditions and legal requirements.
Country-specific salary information will be shared as part of the recruitment process.
For Italy the salary range is between 50,********,000 EUR annual, plus applicable premio and benefits.
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📌 Global Quality Manager (M/F/X) - Eu-Based (Milano)
🏢 csl
📍 Milano