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
Product Quality Lifecycle Management Lead datore di lavoro: Chiesi
Lavorare con noi significa essere parte di un team innovativo e dedicato, impegnato a trasformare la salute nelle malattie rare. Offriamo un ambiente di lavoro flessibile e collaborativo, con opportunità di crescita professionale e sviluppo delle competenze nel campo delle evidenze reali. I nostri dipendenti beneficiano di un programma di benessere completo, supporto per il trasferimento e opzioni di lavoro remoto, rendendo la nostra azienda un datore di lavoro eccezionale per chi cerca un impatto significativo nella sanità.
