Product Quality Lifecycle Management Lead

This is what you will do

The Product Quality Lifecycle Management Lead is an integral part of the Chiesi global organisation and located in the quality department. The position will have overall responsibility for the lifecycle management governance processes for Chiesi’s Air/Care and Rare portfolio of products. This exciting role is a new position, and the successful candidate will have responsibility for implementing and improving the governance process. It will involve partnering primarily with R&D, regulatory, industrialisation, manufacturing sites and quality departments, however connectivity will occur across other departments (engineering and 3rd parties). The role will create a governance process that enables to manage its lifecycle of products in a proactive and collaborative manner across the organisation.

You will be responsible for

Running the Lifecycle Management Governance:

• Runs the Air/Care lifecycle management governance
• Runs the Rare lifecycle management governance
• Connecting with all SME’s and departments for the lifecycle management.
• Opportunities for continuously improving the lifecycle management governance process.
• Ensure the governance process is documented at Chiesi.

Escalation of Lifecycle Management:

• Working cross functionally across departments on ensure lifecycle management activities are followed up and prioritised accordingly.
• Reporting of progress/escalations to the VP of Product Quality Lifecycle Management
• Following up on actions across the wider team for lifecycle management.

Establishing Regulatory Requirements for Lifecycle Management:

• Ensures lifecycle management compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, WHO, PIC/S) and industry standards related to lifecycle management.
• Supports inspection readiness and participates in regulatory inspections and audits related lifecycle management.
• Maintains awareness of evolving regulatory expectations and ensures timely updates to internal policies and practices.

Influence and Collaboration:

• Works closely with R&D, regulatory, industrialisation, manufacturing sites and quality to ensure consistent lifecycle management of Chiesi products.
• Provides guidance and training to global and local teams on lifecycle management principles and practices.
• Fosters a culture of accountability and continuous improvement in lifecycle management across the organization.

You will need to have

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Data Science, Quality Management).
• Extensive experience (10+ years) in quality systems, data governance, and regulatory compliance in the pharmaceutical industry in global roles.
• A broad understanding of lifecycle management principles, GxP requirements, and regulatory expectations.
• Proven track record in collaborative working and team building.
• Strong skills in managing lifecycle management risks and implementing effective governance frameworks.
• Strong project management, communication, and stakeholder engagement skills.
• Ability to influence cross-functional teams and drive change in a matrixed environment.

We would prefer for you to have

• Professional experience across many areas associated with the pharmaceutical development/commercialisation of products.
• Familiarity with digital quality systems and platforms (e.g., Veeva, TrackWise, SAP).
• Experience with data analytics tools and methodologies for risk identification and mitigation.
• Ability to analyse complex data issues and make risk-based decisions

Location

The primary work location is Parma (Italy). The role offers flexibility, allowing candidates to be based across Europe, with regular travel to Parma required.

Budgeted Salary Range