Chiesi USA, Inc.
About Us
Based in Parma, Italy, Chiesi is an international research‑focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas. We are proud to be the largest global pharmaceutical group awarded B Corp Certification, a recognition of high social and environmental standards. Our success is built by our people and a shared set of values.
We are committed to embracing diversity, inclusion and equal opportunities. We are a reliable company that adopts and promotes transparent and ethical behaviour at all levels.
Chiesi Global Manufacturing Division
Chiesi Group has three production plants:
Parma (Italy)
– strategic hub for production and distribution with exports to over 80 countries; solid medicines, inhalers, solutions and sterile vials.
Blois‑La Chaussée Saint Victor (France)
– center of excellence in dry powder inhlers and MDIs, managing direct French market distribution and exports.
Santana de Parnaiba (Brazil)
– production of pressurised solutions, suspensions for inhalation therapy and nasal sprays for the European market.
Upcoming facilities: a new Biotech Centre of Excellence in Parma (2024) and a new plant in Nerviano (Italy, 2025), focusing on monoclonal antibodies, enzymes and dry‑powder inhalers.
Position Overview The Global Quality Process Head is a strategic leader responsible for designing, implementing and maintaining a harmonised, compliant and efficient Quality Management System (QMS) across all global pharmaceutical operations. The 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 harmonisation and simplification of quality processes across sites and functions.
Support the implementation and optimisation 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 in regulatory affairs, IT, operations and engineering.
Lead collaboration forums for QMS quality systems across the network globally with local quality system process owners to drive best practices and continuous improvement.
You will need to have
Bachelor’s degree in Pharmacy, Life Sciences, Engineering or a 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.
Location Hybrid – Parma, Dublin or other strategic locations in Europe.
What We Offer You would join a dynamic, fast‑growing, challenging and friendly environment. We invest in continuous training, learning and development, promoting the collective well‑being and the quality of the working environment. We support a healthy work‑life balance with flexible working approaches, remote work, relocation assistance, tax‑assistance service for foreign colleagues and many other people‑care services.
Seniority Level
Executive
Employment Type
Full‑time
Job Function
Quality Assurance
Pharmaceutical Manufacturing
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We are committed to embracing diversity, inclusion and equal opportunities. We are a reliable company that adopts and promotes transparent and ethical behaviour at all levels.
Chiesi Global Manufacturing Division
Chiesi Group has three production plants:
Parma (Italy)
– strategic hub for production and distribution with exports to over 80 countries; solid medicines, inhalers, solutions and sterile vials.
Blois‑La Chaussée Saint Victor (France)
– center of excellence in dry powder inhlers and MDIs, managing direct French market distribution and exports.
Santana de Parnaiba (Brazil)
– production of pressurised solutions, suspensions for inhalation therapy and nasal sprays for the European market.
Upcoming facilities: a new Biotech Centre of Excellence in Parma (2024) and a new plant in Nerviano (Italy, 2025), focusing on monoclonal antibodies, enzymes and dry‑powder inhalers.
Position Overview The Global Quality Process Head is a strategic leader responsible for designing, implementing and maintaining a harmonised, compliant and efficient Quality Management System (QMS) across all global pharmaceutical operations. The 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 harmonisation and simplification of quality processes across sites and functions.
Support the implementation and optimisation 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 in regulatory affairs, IT, operations and engineering.
Lead collaboration forums for QMS quality systems across the network globally with local quality system process owners to drive best practices and continuous improvement.
You will need to have
Bachelor’s degree in Pharmacy, Life Sciences, Engineering or a 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.
Location Hybrid – Parma, Dublin or other strategic locations in Europe.
What We Offer You would join a dynamic, fast‑growing, challenging and friendly environment. We invest in continuous training, learning and development, promoting the collective well‑being and the quality of the working environment. We support a healthy work‑life balance with flexible working approaches, remote work, relocation assistance, tax‑assistance service for foreign colleagues and many other people‑care services.
Seniority Level
Executive
Employment Type
Full‑time
Job Function
Quality Assurance
Pharmaceutical Manufacturing
#J-18808-Ljbffr