Who we are looking for Position Overview The Global Quality Process Head is a strategic leader responsible for designing, implementing, and maintaining a harmonized, compliant, and efficient Quality Management System (QMS) across all global pharmaceutical operations.
This role ensures alignment with regulatory requirements, supports product lifecycle management and drives a culture of continuous improvement and quality excellence.
You will be responsible for Develop and lead the global QMS strategy, ensuring alignment with business goals and regulatory expectations.
Establish governance frameworks for quality systems oversight Ensure QMS compliance with global regulatory standards Oversee core QMS processes: CAPA, Change Control, Deviations, Document Management Training Drive harmonization and simplification of quality processes across sites and functions.
Support the implementation and optimization of electronic QMS platforms (e.g., Veeva Vault QMS and QDocs) Lead global training needs for the global quality organisation Lead and develop a global team of quality systems professionals Collaborate cross functionally with stakeholders reg affairs, IT, operations, engineering Lead collaboration forums for QMS quality systems across the network globally with the local quality system process owners to drive best practices and continuous improvements You will need to have Bachelor's degree in Pharmacy, Life Sciences, Engineering, or related field (Master's or PhD preferred).
Minimum 15 years of experience in pharmaceutical quality systems, with at least 5 years in a global leadership role.
Deep understanding of global pharmaceutical regulations and GxP requirements.
Proven experience in leading QMS transformations and digital implementations.
Strong leadership, communication, and stakeholder engagement skills.
We would prefer for you to have Experience with regulatory inspections (FDA, EMA, PMDA, etc.).
Expertise in clinical commercial GMP/GDP quality systems.
Experience working and leading in a global matrixed work environment an advantage Location Hybrid – Parma, Dublin or other strategic locations in Europe What we offer You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.
Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.
That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.