Site Quality Head
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.
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.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)