Job Description Summary
Join the QA compliance team and help ensure robust compliance and effective implementation of the Novartis Quality Management System. In this role, you will safeguard that all site and product-related activities meet cGxP requirements including data integrity, Novartis quality standards, and applicable international and local regulations, supporting the consistent delivery of high-quality medicines to patients.
You will act as a site subject-matter expert in the Novartis Change Control process partnering closely with Manufacturing, Engineering, QC laboratories, MS&T, Supply Chain, QA departments and external partners. You will be the bridge between the global Novartis change control process owners and the users in the manufacturing site, keeping the site up to speed with the process and supporting and representing the site with global stakeholders in the process. Through your contributions to the change control process you will strengthen compliance, support projects and innovations, make a meaningful impact across our operations and finally for the people relying on our medicines.
Job Description
Major Accountabilities:
- Ensure the Change Control process is applied compliant with global Novartis process and documented in 1QEM.
- Collaborate with other Change Control stakeholders in Novartis Manufacturing and supporting QOP team to implement, improve and enforce the process.
- Monitor and report Change Control KPIs.
- Implement, maintain, and continuously improve processes and governance, aligned with Novartis standards and applicable regulations.
- Review, coordinate, and drive timely completion of deviations, investigations, CAPAs, and effectiveness checks, with strong focus on preventing recurrence.
- Prepare for and support audits and regulatory inspections, including readiness activities.
- Provide clear explanations of Change Control processes during audits in collaboration with change owners.
- Keep assigned procedures accurate, updated, and aligned with evolving operational requirements.
Obligatory requirements:
- Master’s degree in a scientific field such as Pharmacy, Industrial Pharmacy, Bio‑engineering, or related discipline.
- Experience in a regulated environment, preferably within the pharmaceutical industry.
- Proficiency in computer systems with the ability to work accurately with digital documentation.
- Excellent communication skills with the ability to collaborate effectively across teams and with external partners.
- Main language is Dutch, fluency in English is also required.
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.
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.
Skills Desired
