Validation Director

**Date**:5 May 2025

**Department**:GRD Quality Operations

**Business Area**:Quality

**Job Type**:Direct Employee

**Contract Type**:Permanent

**Location**:Parma, 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_**

**Purpose**-
**Main Responsibilities**
- Leadership: Lead and manage the validation team to ensure all validation activities are conducted in compliance with regulatory requirements and industry standards. Provide leadership and guidance on validation-related issues, including troubleshooting and problem-solving.
- Documentation: Develop, implement, and maintain validation protocols and procedures for equipment, processes, and facilities. Ensure timely and accurate documentation of all validation activities and results. Prepare and present validation reports to senior management and regulatory authorities.
- Qualification: Oversee the execution of validation studies, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Issue Resolution: Investigate validation and qualification failures, and deviations, ensure timely and effective resolution, and implement corrective and preventive actions.
- Risk Assessments: Conduct risk assessments and develop mitigation strategies for validation-related issues.
- Collaboration: Collaborate with cross-functional teams, including quality assurance, manufacturing, and engineering, to support validation efforts.
- Continuous Improvement: Ensure continuous improvement of validation processes and procedures. Design and execute initiatives to enhance compliance, efficiency, and cost-effectiveness.
- Regulatory Compliance: Ensure the validation and qualification activities and documentation is suitable for regulatory inspections.
- Budget Management: Prepare and manage the site quality budget for validation activities, ensuring expenditures align with projections.
- Resource Management: Ensure adequate resources, including manpower, to maintain compliance with GxP requirements for validation and qualification activities.
- Governance: Prepare and present validation