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Global Quality Manager (m/f/x) - EU-based
Employment: Full-time, Permanent You 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.
Reporting to the Affiliate Quality Head, US & Quality Systems, Standards & Governance,
you will:
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 ele
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