Overview
In this role, you will lead global quality operations activities to ensure consistency across Chiesi Farmaceutici sites. You will drive harmonized quality practices, monitor KPIs, and support governance and change control. You will partner with site Quality Directors to address cross-site challenges and uphold regulatory compliance. Your work will foster a culture of quality excellence that supports safe, compliant products and continuous improvement at scale.
Retribuzione / Benefits
- comprehensive healthcare
- work-life balance initiatives
- relocation support
- performance bonuses
- flexible working arrangements
- remote work options
Responsabilità
- Coordinate integrated quality operations across sites, monitor quality KPIs, and manage non-conformities, deviations, and change control.
- Cascade guidelines and SOPs and support local implementation.
- Ensure validation processes are compliant and contribute to Validation Project Plans and Final Reports for major internal projects.
- Collaborate with Quality Directors at each site to address cross-site challenges and support governance through the Quality Council.
- Work with Compliance teams to ensure quality standards meet internal and regulatory requirements.
- Provide strategic leadership to foster a culture of quality excellence throughout the organization.
Requisiti fondamentali
- Minimum 10 years of pharmaceutical quality assurance experience, with at least 5 years in quality operations.
- Deep knowledge of quality management systems, compliance standards, and regulatory requirements in pharma.
- Demonstrated leadership across multiple sites with cross-functional collaboration.
- Experience in change management and governance framework development.
- Excellent communication for presenting complex issues to stakeholders.
- Strategic thinking to analyze processes and implement effective improvements.
- English fluency (spoken and written).
- Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook, Teams) and project management tools (e.g., Microsoft Project).
- Familiarity with TrackWise or Veeva QualityDocs for quality documentation.
- leadership
- cross-functional collaboration
- strategic thinking
- quality management systems
- regulatory compliance
- change management
Global Operational Compliance Lead datore di lavoro: Chiesi
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