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
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 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.
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 and industry standards.
Demonstrated ability to work independently, take ownership of assigned projects, and deliver results with minimal supervision.
Excellent interpersonal skills with the ability to build effective cross-functional relationships and work successfully
📌 Quality Manager with SAP (Italia)
🏢 CSL Plasma
📍 Italia
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