Head of Validation and compliance

Date: 1 Aug 2025

Department: Corporate Engineering

Business Area: Industrial Operations & HSE

Job Type: Direct Employee

Contract Type: Permanent

Location:

Milano, IT

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

Job Purpose

For our new Site in Nerviano (Milan) we are looking for a new Head of Validation and Compliance.

The Head of Validation & Compliance is responsible for leading and managing all validation and compliance activities related to equipment, facilities, and utilities at the pharmaceutical manufacturing site, specialized in respiratory spray products and biopharmaceuticals. This role ensures that validation strategies are in alignment with regulatory expectations and internal quality standards, and that they effectively support ongoing operations and project initiatives.

Key Responsibilities

Develop, maintain, and ensure the implementation of the Validation Master Plan (VMP) for equipment and utilities.
Oversee the validation lifecycle (IQ/OQ/PQ) of process equipment, utilities, and critical systems (e.g., HVAC, WFI, clean steam, compressed air).
Manage the Compliance & Validation team, planning resources to support both routine operations and strategic project-based activities.
Ensure alignment with GMP, FDA, EMA, and ICH guidelines, and proactively prepare for audits and inspections.
Coordinate validation activities with cross-functional teams, including Engineering, Production, Quality Control, and QA.
Evaluate and approve change controls and deviations impacting validation status.
Establish and monitor relevant KPIs and metrics to ensure continuous improvement and risk-based validation approaches.
Act as the validation SME (Subject Matter Expert) during internal and external audits.
Lead training and development plans for the validation & compliance team.
Collaborate with project managers to define validation deliverables for new equipment, process changes, or site expansion.

Required Qualifications & Experience

Degree in Engineering, Pharmacy, Chemistry, or related scientific discipline.
Minimum 8–10 years of experience in pharmaceutical validation, with at least 3 years in a leadership role.
Solid knowledge of EU GMP, FDA CFR 21 Part 11, Annex 15, GAMP 5, and validation best practices.
Experience with aseptic/sterile production, preferably in respiratory devices and biopharmaceuticals.
Demonstrated experience in equipment and utilities validation, including HVAC, purified water systems, and clean rooms.
Strong understanding of risk management methodologies (e.g., FMEA, QRM).

Languages

Proficiency in English (written and spoken)

Technical Skills

Validation protocols and lifecycle management (IQ/OQ/PQ).
Compliance with global regulatory standards.
Data integrity principles and computerized system validation (CSV).
Deviation and change control management.
Project management and resource planning tools.

Soft Skills

Strong leadership and team development capabilities.
Excellent communication and interpersonal skills.
Problem-solving mindset and ability to work under pressure.
High attention to detail and organizational skills.
Strategic thinking with a proactive, hands-on approach.
Cross-functional collaboration and stakeholder management.

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.