Product Quality Lifecycle Management Lead

3 ore fa

Bergamo, Lombardy, 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