Descrizione:
Summary
Location: Ivrea, Italy
This role is based in Ivrea, Italy. Novartis is unable to offer relocation support: please only apply if this location is accessible.
Step into a pivotal leadership role where quality, compliance, and patient safety come together. As Site Quality Head, you will shape and safeguard the quality strategy of a complex manufacturing site, ensuring full compliance with global quality standards while enabling business continuity and innovation. You will lead and inspire a multidisciplinary quality organization, act as a trusted partner to site and global leadership, and play a critical role in Health Authority engagement and inspection success. This role offers the opportunity to make a visible impact—driving a strong quality culture, supporting launches, and ensuring that every product released meets the highest standards of safety, quality, and regulatory excellence.
About The Role
Key Responsibilities:
- Lead site Quality strategy ensuring full compliance with cGMP, regulatory requirements, and corporate quality standards.
- Establish and maintain an effective site quality organization, governance model, and decision‑making framework.
- Own site quality systems including deviations, investigations, change control, product quality reviews, and documentation lifecycle.
- Ensure continuous inspection readiness and successfully host Health Authority inspections and follow‑up activities.
- Act as Qualified Person (Deputy), independently overseeing batch certification and release in line with legal requirements.
- Drive strong quality risk management, escalation processes, and timely health authority notifications where required.
- Develop and embed a strong quality culture through training, self‑inspections, and continuous improvement initiatives.
- Provide leadership input for quality talent selection, development, succession planning, and launch readiness support.
- Lead, coach, and develop quality leaders and teams to ensure sustainable performance and regulatory excellence.
Essential Requirements
- Bachelor’s degree in a scientific discipline such as pharmacy, chemistry, biology, or a related field.
- Minimum five years of experience in pharmaceutical Quality Assurance or Quality Control within a regulated manufacturing environment.
- Strong working knowledge of Good Manufacturing Practice regulations and pharmaceutical quality management systems.
- Proven experience leading quality organizations, including people management, development, and performance oversight.
- Demonstrated experience preparing for, hosting, and responding to Health Authority inspections.
- Fluent English communication skills, both written and spoken, in a global and cross‑functional environment.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
#J-18808-Ljbffr