Complaint Corporate Process Owner

Il y a 4 heures
Brainel'Alleud, Wallonia, Belgique Pauwels Consulting Temps plein
pOur client, a leading biopharmaceutical organization, is seeking a Complaint Corporate Process Owner to manage and optimize global complaint management systems. This role ensures process compliance with international regulations while driving operational excellence through cross-functional collaboration and strategic oversight. /pulliLead the global GMP Complaint Management process, overseeing procedural requirements and associated documentation. /liliManage the performance of the outsourced central complaint unit, ensuring adherence to quality and training standards. /liliEstablish governance models for continuous process improvement and monitoring through key indicators and performance reporting. /liliAct as the primary eQMS super user for complaint flows, providing technical support and system enhancement feedback. /liliMaintain inspection readiness for procedural documents and participate in internal and external quality audits. /liliAnalyze product complaint data and generate trending reports for presentation to senior leadership. /liliCollaborate with global stakeholders to ensure alignment and promote best practices across manufacturing sites and affiliates. /li /ululliYou possess 8+ years of leadership experience, including the management of teams and large-scale quality processes. /liliYou bring expert knowledge of bGMP /b quality principles and manufacturing expertise in bDrug Substance /b or bDrug Product /b. /liliYou're experienced in risk management, including the oversight of bCAPAs /b, bdeviations /b, and audit observations. /liliYou have a strong process improvement mindset with the ability to analyze complex data in bExcel /b to draw strategic conclusions. /liliYou possess excellent interpersonal skills and the ability to influence senior internal and external stakeholders. /liliYou are fluent in bEnglish /b. /li /ulh3Nice to Haves /h3ulliExperience with bCombination Product /b and bDevice QMS /b regulatory requirements. /liliKnowledge of bFrench /b. /li /ul

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