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 mínimal 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