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The Complaint and Escalation Management Quality Lead is a global contractor role within the Global Quality Organization. Reporting to the Head of Complaint and Escalation Management, the incumbent serves as the Corporate Process Owner (CPO) for the Escalation Management process and provides operational support for Corporate Complaints.
Job Responsibility:
Process Ownership: manage the end-to-end Corporate Escalation process, including global documentation (policies, standards, procedures) and training materials
Network Leadership: lead the Escalation Management Network, facilitating meetings and collaborating with Entity Process Owners (EPOs) across manufacturing sites and affiliates
Compliance & Quality: ensure all processes align with authority regulations and maintain constant inspection readiness
Operational Support: manage deviations, CAPAs, and audit responses while acting as a back-up for the Complaints Management CPO
Performance Monitoring: generate KPI data and data analytics to drive continuous process improvement
Requirements:
At least 10 years in the pharmaceutical/biologics industry within a Quality Assurance role
Deep expertise in GMP investigations (root cause analysis, CAPA identification, ...) and eQMS systems
Profond knowledge within Drug Substance and/or Drug Product manufacturing and good understanding of applicable regulations
Strong leadership, conflict resolution, and the ability to influence senior stakeholders in a multi-cultural environment