Product Quality Lifecycle Management Lead

28 set - La Spezia
Chiesi

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

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