Quality Assurance
2 settimane fa
*Please note that this is an on site role in Europe, relocation required for the duration of the contract and candidates must have an EU passport*
Strategic Leadership & Governance
- Develop and implement the overall strategy for backlog deviation management and prevention.
- Establish governance frameworks, escalation pathways, and KPI dashboards for global and site-level visibility.
- Provide executive-level reporting, insights, and recommendations to senior leadership.
Cross-Functional Direction
- Lead cross-functional teams to ensure timely closure of high-risk deviations and associated CAPAs.
- Partner with Operations, Quality Assurance, Manufacturing, Engineering, and Supply Chain leaders to align resources and priorities.
- Facilitate high-level decision-making sessions and risk reviews.
Process Optimization & Prevention
- Drive systemic root-cause identification and translate findings into sustainable process improvements.
- Introduce or refine standards, SOPs, workflows, and digital tools supporting deviation lifecycle management.
- Define and track critical KPIs such as backlog aging, closure effectiveness, recurrence rates, and documentation quality.
Coaching & Capability Building
- Mentor teams in investigation quality, RCA methodologies, and best practices for deviation/CAPA management.
- Promote a culture of accountability, continuous improvement, and proactive risk mitigation
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