Head of Validation and compliance

Who we are looking for

Job Purpose

For our new site in Nerviano (Milan), we are seeking a Head of Validation and Compliance.

The Head of Validation & Compliance will lead all validation and compliance activities related to equipment, facilities, and utilities at our pharmaceutical manufacturing site, which specializes in respiratory spray products and biopharmaceuticals. This role ensures validation strategies align with regulatory expectations and internal quality standards to support ongoing operations and projects.

Key Responsibilities

1. Develop and implement the Validation Master Plan (VMP) for equipment and utilities.
2. Oversee the validation lifecycle (IQ / OQ / PQ) for process equipment, utilities, and critical systems such as HVAC, WFI, clean steam, and compressed air.
3. Manage the Validation & Compliance team, planning resources to support routine operations and strategic projects.
4. Ensure compliance with GMP, FDA, EMA, and ICH guidelines, and prepare for audits and inspections.
5. Coordinate validation activities with cross-functional teams including Engineering, Production, Quality Control, and QA.
6. Review and approve change controls and deviations affecting validation status.
7. Monitor KPIs and metrics to drive continuous improvement and risk-based validation approaches.
8. Serve as the validation Subject Matter Expert during audits.
9. Lead training and development for the validation & compliance team.
10. Collaborate with project managers to define validation deliverables for new equipment, process changes, or site expansion.

Required Qualifications & Experience

1. Degree in Engineering, Pharmacy, Chemistry, or related scientific discipline.
2. 8–10 years of experience in pharmaceutical validation, including at least 3 years in a leadership role.
3. Strong knowledge of EU GMP, FDA CFR 21 Part 11, Annex 15, GAMP 5, and validation best practices.
4. Experience with aseptic/sterile production, preferably in respiratory devices and biopharmaceuticals.
5. Proven experience in equipment and utilities validation, including HVAC, water systems, and clean rooms.
6. Understanding of risk management methodologies (e.g., FMEA, QRM).

Languages

Proficiency in English (written and spoken)

Technical Skills

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

Soft Skills

1. Leadership and team development skills.
2. Excellent communication and interpersonal abilities.
3. Problem-solving skills and ability to work under pressure.
4. Attention to detail and organizational skills.
5. Strategic thinking with a proactive, hands-on approach.
6. Ability to collaborate across functions and manage stakeholders.

What we offer

Join a dynamic, fast-growing, challenging, and friendly environment.

At Chiesi, we believe our people are our greatest asset. We invest in continuous training, learning, and development, fostering a positive working environment and collective well-being.

We support work-life balance with flexible working arrangements, remote work options, relocation assistance, tax services for foreign colleagues, and other people-care initiatives.