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 DocNet.
- 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 GxP-regulated role.
- Strong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines a

📌 Quality Manager (Milano)
🏢 CSL Plasma
📍 Milano