Job Description Summary
#LI-Onsite
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.
Job Description
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.
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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.
Skills Desired
Analytical Thinking, Business Acumen, Business Strategy, Collaboration, Communication Skills, Data Integrity, Decision Making, Digital saviness, Finance Acumen, Industry standards Knowledge, Leadership, Organizational Saviness, Risk Management, Smart Risk Taking, Stakeholder Management, Storytelling, Strategic Planning, Strategic Thinking