Head of Quality Process

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:
Discover more here

We are proud to be the largest global pharmaceutical group to be awarded
B Corp Certification
, a recognition of
high social and environmental standards
. We are a
reliable
company that adopts and promotes a
transparent and ethical behavior
at all levels.

We believe that the success of
Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors
. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to
embrace diversity, inclusion and equal opportunities.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Global Manufacturing Division

Chiesi Group has three production plants:

Parma
(Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.

In 2024, a new
Biotech Centre of Excellence
has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.

Blois-La Chaussée Saint Victor plant
(France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.

Santana de Parnaiba
(Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).

In 2025, a new investment in
Nerviano
(Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company's commitment to both patients' health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.

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