Quality manager
Pubblicato il 07-10-2026 - CSL Plasma in Milano
Quality Manager (m/f/x) - EU-based Location: 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. Employment: Full-time, Permanent The Role: Establish and maintain processes for reporting Quality KPIs across global affiliates. Coordinate inspection readiness activities throughout the global affiliate network.
Support quality management system compliance activities, ensuring policies, SOPs, work instructions, and related documentation remain current, effective, and aligned with business and regulatory requirements. Manage the integration of Affiliate Quality SOPs with Global CSL procedures and facilitate procedure updates to incorporate affiliate and local requirements. Provide quality support to US Commercial Operations as required. Support Product Technical Complaint (PTC) activities for the US market.
Support Global Change Control, Deviation, and CAPA processes across assigned regions.
Support and perform product release activities for the US market and Kankakee-manufactured export products, collaborating with manufacturing site representatives as needed. Lead and/or support implementation of global electronic quality systems such as SAP, Master Data Governance, and Doc Net. Ensure effective communication with internal and external stakeholders regarding progress, improvements, risks, and compliance-related matters.
Your Skills and Experience: Bachelor'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. Minimum of 2 years' experience in a pharmaceutical industry Gx P-regulated role. Strong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines and industry standards.
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