Product Quality Lifecycle Management Lead

2 giorni fa

Campania, Italia Chiesi Tempo pieno
Overview You will lead the governance of lifecycle management for Chiesi's Air/Care and Rare products, partnering with R&D, regulatory, manufacturing and quality teams to drive proactive lifecycle practices. This role anchors governance documentation and ensures regulatory compliance across global markets, while enabling cross-functional collaboration and continuous improvement. You will shape how lifecycle decisions are made and escalate progress to senior leadership. This is a strategic, cross-organizational role that anchors quality and compliance in a growing portfolio. Retribuzione / Benefits
* pension
* private medical insurance
* wellbeing programme
* flexible benefits programme
* relocation support
* remote work options Responsabilità
* Lead the Air/Care and Rare lifecycle management governance programs
* Engage SMEs and departments to align lifecycle actions
* Identify and drive continuous improvement of governance processes
* Document governance and ensure traceability across sites and functions
* Escalate progressive issues and report to the VP, Product Quality Lifecycle Management
* Ensure regulatory requirements for lifecycle management are met (FDA, EMA, MHRA, WHO, PIC/S) and support inspections
* Provide guidance and training on lifecycle management principles and practices
* Foster accountability and cross-functional collaboration across R&D, regulatory, manufacturing and quality Requisiti fondamentali
* Bachelor's degree in Life Sciences, Engineering, Data Science, or Quality Management
* 10+ years of experience in quality systems, data governance, and regulatory compliance in a global pharma context
* Strong understanding of lifecycle management, GxP, and regulatory expectations
* Proven track record in collaborative work and team building
* Strong project management, communication, and stakeholder engagement skills
* Ability to influence cross-functional teams and drive change in a matrixed environment
* collaborative mindset
* strong communication
* stakeholder engagement
* GxP knowledge
* data governance
* regulatory compliance