Skrbnik upravlj. produktov – QM&L (m/ž/d) / Business Product Owner – CellChain Quality, Manufacturing & Labelling (m/f/d)

Salary Range: 46.900,00 € - 87.100,00 € Job Description Summary #LI-Hybrid Location: Ljubljana, Slovenia Relocation Support: This role is based in Ljubljana, Slovenia. Novartis is unable to offer relocation support: please only apply if accessible. About the role: Prevzemite pomembno vlogo pri podpori personaliziranim CAR-T zdravilom ter zagotavljanju zanesljive in neprekinjene oskrbe bolnikov. Odgovorni boste za ključne GxP funkcionalnosti sistema CellChain na področjih kakovosti, proizvodnje, sproščanja serij, označevanja in sledljivosti identitete (Chain of Identity). Vaša odgovornost bo vključevala tudi upravljanje produkta, odobravanje sprememb ter zagotavljanje skladnega sproščanja na trgih ZDA in drugih mednarodnih trgih. Take on a key role supporting personalised CAR-T products and helping ensure continuity of patient supply. You will be responsible for global GxP back-end capabilities supporting quality, manufacturing, batch release, labelling and Chain of Identity, including product governance, change approvals and compliant releases across the US and international markets. At the same time, you will lead the NTO CellChain team, ensuring continuity and supporting reliable patient supply, while working in accordance with legislation, internal requirements, good practices and business objectives. Job Description Vaše ključne odgovornosti: Reševanje težav, povezanih s proizvodnimi lokacijami, sproščanjem serij, označevanjem in pretokom podatkov, v okviru opredeljenih zahtev kakovosti ter upravljanje povezanih eskalacij. Ohranjanje razumevanja poslovnih razlogov za obstoječe kontrole in konfiguracije ter s tem podpora neprekinjenemu delovanju sistema CellChain in ohranjanju ključnega znanja. Prepoznavanje priložnosti za izboljšave procesov na področjih kakovosti, levkafereze, odločanja o ustreznosti serij in označevanja v sodelovanju s ključnimi poslovnimi deležniki. Spodbujanje standardizacije in zmanjševanje lokalnih odstopanj z namenom ohranjanja celovitosti globalne zasnove produkta. Podpora učinkovitemu povezovanju rešitev CellChain z regionalnimi rešitvami ter zagotavljanje celovitosti produkta. Vodenje in usklajevanje ključnih odločitev glede zasnove z lastniki poslovnih procesov in deležniki s področja kakovosti. Sodelovanje z ekipami Digital, Data and Information Technology pri zasnovi produkta, tehničnih integracijah in zagotavljanju stalne operativne podpore. Zagotavljanje skladnosti z dobro proizvodno prakso (GMP), zahtevami GxP, validacijo računalniških sistemov ter veljavnimi regulatornimi zahtevami. Spodbujanje stalnih izboljšav funkcionalnosti sistema CellChain, ki podpirajo personalizirana CAR-T zdravila, ter prispevanje k nadaljnjemu razvoju produkta. Ključne zahteve Visokošolska stopnja izobrazbe s področja narovoslovja, inžiniringa, oskrbe, financ ali druge ustrezne smeri. Najmanj 5 let uspešnih delovnih izkušenj v farmacevtski industriji, od tega vsaj 2 leti na področju zagotavljanja kakovosti, označevanja ali proizvodnih operacij, oziroma primerljive izkušnje na sorodnem področju. Poznavanje in uporaba sodobnih digitalnih in tehnoloških orodij ter sistemov, vključno z rešitvami, ki vključujejo umetno inteligenco. Aktivno znanje slovenskega in angleškega jezika. Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas . Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku. Nagrajevanje: V Novartisu smo zavezani k soustvarjanju prihodnosti medicine ter priznavanju in nagrajevanju ljudi, ki to omogočajo. Pričakovani letni osnovni razpon plače za delovno mesto: 46.900 € – 87.100 € Osnovna plača se določa na podlagi vnaprej opredeljenih in transparentnih kriterijev, kot so relevantne veščine, kompetence in izkušnje, ne glede na spol, ter v skladu z Novartisovo politiko določanja plač. Po zaposlitvi v Novartisu se plača periodično pregleda v skladu z internimi akti in postopki. Plačna enakost je temeljno načelo naše kadrovske politike in odraža našo zavezo k ustvarjanju raznolikega, pravičnega in vključujočega okolja, ki vse zaposlene obravnava dostojanstveno in spoštljivo, kot je opredeljeno v našem Kodeksu etike. Poleg osnovne letne bruto plače so zaposleni upravičeni tudi do spodaj navedenih ugodnosti: Letni bonus, ki pripada vsakemu zaposlenemu: 15% letne plače. Regres za dopust : Leta 2025 je znašal 2.496 € (neto). Za leto 2026 znaša 2.678,28 € (neto). Nagrada za poslovno uspešnost : Leta 2025 je znašala 2.538,64 € (bruto), skupaj z zimskim regresom. Prostovoljno dodatno pokojninsko zavarovanje : Novartis v Sloveniji zagotavlja prostovoljno dodatno pokojninsko zavarovanje (5,844 % bruto izplačila, letno omejeno na 3.054,65 €). Zavarovanje: Dodatno nezgodno zavarovanje: V času zaposlitve pri Novartisu je zaposleni 24/7 zavarovan za primer smrti ali invalidnosti, ki bi bila posledica nezgode. Zavarovanje – Specialisti : Kolektivno zdravstveno zavarovanje, ki omogoča hitrejši dostop do specialističnih zdravstvenih storitev pri Zavarovalnici Triglav d.d. za vas in vaše družinske člane. Care Connect: Program, ki ponuja zaupno, osebno podporo za vaše duševno zdravje in dobro počutje s pomočjo terapij, svetovanj, orodij in še mnogo več. Ostale ugodnosti v skladu z zakonom in kolektivno pogodbo: Prevoz, prehrana ter ostali dodatki. Preberite brošuro in izvedite več o našem sistemu nagrajevanja: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Opomba: Ugodnosti se lahko razlikujejo glede na državo ter so skladni z lokalno zakonodajo, vključno z določili kolektivnih pogodb. Celovit pregled vašega paketa prejemkov, vključno z morebitnimi relevantnimi določbami kolektivne pogodbe, ki veljajo za vašo delovno mesto glede na lokacijo zaposlitve in delodajalca Novartis, vam bo posredovan v okviru nadaljnjih korakov zaposlitvenega postopka. Predani smo raznolikosti in vključenosti: Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo. ________________________________________________________ Key responsibilities: · Resolve plant, batch-release, labelling and data-flow issues within defined Quality boundaries and manage relevant escalations. · Maintain 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 effective integration between CellChain products and regional solutions, contributing to overall product integrity. · 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 Good Manufacturing Practice, GxP, computerised system validation and applicable regulatory requirements. · Drive continuous improvement of CellChain capabilities supporting personalised CAR-T products and contribute to the overall roadmap. . Essential requirements: Minimum 5 years of experience successfully working in the pharmaceutical industry, with at least 2 years in a function with QA, labelling or manufacturing operations focus, or equivalent experience in a related field. Knowledge and use of modern digital, technological, and AI enabled tools and systems. Proficiency in Slovene and English language, where required by the work process. University education in natural sciences, Engineering discipline, Quality, Manufacturing or other relevant field. We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language. Rewards: At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: 46.900 € – 87.100 € The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. In addition to your base salary, you will be eligible for benefits listed below: Annual bonus for all employees: 15% of annual base salary. Holiday allowance: In 2025 it amounted to €2,496 (net). For 2026 it amounts to €2,678.28 (net). Yearly performance-based bonus: In 2025 it amounted to €2,538.64 (gross), including the winter allowance. Voluntary supplementary pension insurance: Novartis in Slovenia provides voluntary supplementary pension insurance (5.844% of gross salary, capped annually at €3,054.65). Insurance: Additional accident insurance: During employment at Novartis, the employee is insured 24/7 in the event of death or disability resulting from an accident. Specialist insurance: Group health insurance providing faster access to specialist healthcare services at Triglav Health Insurance Company d.d. for you and your family members. Care Connect: A program offering confidential, personalized support for mental health and well-being through therapy, counselling, tools, and more. Other benefits in accordance with legislation and collective agreements: Transportation, meal allowance, and other supplements. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process. 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 Data Analytics, Emotional Resilience, Integrated Business Planning (IBP), Inventory Management, Leadership, Master Data, Operational Excellence, Project Management, Risk Management, SAP Enterprise Resource Planning (ERP), Stakeholder Management, Supply Chain Planning (SCP), Transportation And Logistics