CellChain Quality, Manufacturing & Labelling (m/f/d)
Novartis in Slovenia · Ljubljana
Opis delovnega mesta
About the role
Novartis is looking for a Business Product Owner for its CellChain system, which supports personalised CAR-T medicines. The role covers global GxP back-end capabilities for quality, manufacturing, batch release, labelling and Chain of Identity, including product governance, change approvals and compliant releases across the US and international markets. It also leads the NTO CellChain team and ensures continuity of patient supply. The position is based in Ljubljana, Slovenia, and Novartis does not offer relocation support.
Key responsibilities
- Resolve plant, batch-release, labelling and data-flow issues within defined quality boundaries and manage related escalations.
- Maintain understanding of the business rationale behind existing controls and configurations, supporting CellChain continuity and knowledge retention.
- Identify improvement opportunities across quality, leukapheresis, batch disposition and labelling processes with key business stakeholders.
- Drive standardisation and reduce local variations to protect the integrity of the global product design.
- Support integration between CellChain products and regional solutions.
- Drive and align key design decisions with business process owners and Quality stakeholders.
- Partner with Digital, Data and Information Technology on product design, technical integration and ongoing operational support.
- Ensure compliance with GMP, GxP, computerised system validation and regulatory requirements.
- Drive continuous improvement of CellChain capabilities supporting personalised CAR-T products.
Required profile
- University education in natural sciences, engineering, quality, manufacturing or another relevant field.
- At least 5 years of successful experience in the pharmaceutical industry, including at least 2 years in a function focused on quality, labelling or manufacturing operations, or equivalent experience in a related field.
- Active knowledge of Slovenian and English.
Required skills
- Knowledge and use of modern digital and technological tools and systems, including AI-enabled solutions.
What we offer
- Permanent employment with a 6-month probation period; expected annual base salary of 46,900 to 87,100 EUR.
- Annual bonus of 15% of base salary, holiday allowance and a performance-based bonus.
- Voluntary supplementary pension insurance, accident insurance and group health insurance.
- Care Connect programme for mental health and well-being, plus transportation, meal allowance and other statutory benefits.
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Novartis in Slovenia
Ljubljana
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