About the Role
Major Accountabilities:
- Support site qualification and validation activities (advising, review, approval).
- Implementation of Quality Systems (incl. documentation management)
- Supplier management activities (agreements, oversight, audit).
- Preparation/support and coordination of CAPA/follow -up
- Audit and inspection preparation and support, ensure applications, certificate maintenance etc. to local HA
- Change control review/approval
- Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc)
- KPI/KQI trending
- Handling of technical complaints, deviations, quality events related to Novartis products, systems or processes.
Key Performance Indicators:
- Successful support of projects with agreed quality and delivery dates, passing of internal & external inspections.
- Meet quality & timelines for all projects
- Act in accordance with Novartis standards.
- The number and severity of cGMP issues identified during internal and external audits
- Year-end figures within budget; Successful coordination of departmental operational activities
Work Experience:
- Change Control Management
- Audit & Inspection Management
- Compliance Risk Management
- Good Manufacturing Practices (cGMP)
- GxP Experience
- KPI Reporting
- Quality Management System
Prerequisites:
- Minimum of 5 years in pharmaceutical industry (sterile preferred)
- Previous experience in HAs inspection support (backroom / SME)
- Experienced in QMS document management
- Fluency in English
- Experience working with electronic quality systems (e.g. change controls, deviations, OOX, complaints, etc.)
- Strong quality mindset, documentation, communication, and cross‑functional collaboration skills.
Languages:
- Italian
- English
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)
