Summary
Lokacija / Location: Ljubljana, Slovenia
Če vas navdihuje misel, da je lahko vsaka pošiljka življenjska vez za bolnika, vas bo ta vloga postavila v središče zagotavljanja kakovosti izdelkov v globalnem distribucijskem omrežju. Aktivno boste oblikovali in krepili zagotavljanje kakovosti (Quality Assurance) v farmacevtski distribuciji z vzpostavljanjem najboljših praks, usmerjanjem odločitev na podlagi tveganj ter tesnim sodelovanjem z ekipami dobavne verige in zunanjimi logističnimi partnerji, da bodo procesi vedno pripravljeni na inšpekcije in se bodo nenehno izboljševali. Od nadzora distribucijskih aktivnosti in skrbnega pregleda poslovnih partnerjev do obravnave odstopanj, revizij in sledljivosti serij – vaše delo bo neposredno varovalo bolnike in krepilo zaupanje v način, kako zdravila vsak dan potujejo do njih.
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If you’re energized by the idea that every shipment can be a patient’s lifeline, this role puts you at the heart of protecting product quality across a global distribution network. You will shape and strengthen Quality Assurance for pharmaceutical distribution by setting best practices, guiding risk based decisions, and partnering closely with supply chain teams and external logistics partners to keep processes inspection ready and continuously improving. From oversight of distribution activities and trading partner due diligence to deviations, audits, and batch traceability, your work will directly safeguard patients and reinforce trust in how medicines move—every day.
Relocation Support: This role is based in Ljubljana, Slovenia. Novartis is unable to offer relocation support: please only apply if accessible.
About the Role
Vaše ključne odgovornosti:
- Opredeljevanje in nenehno razvijanje globalne strategije zagotavljanja kakovosti v upravljanju dobavne verige v skladu z dobro distribucijsko prakso (GDP).
- Zagotavljanje celovite skladnosti z dobro proizvodno prakso (GMP), dobro distribucijsko prakso (GDP) in regulatornimi zahtevami v vseh distribucijskih dejavnostih od začetka do konca.
- Izvajanje nadzora zagotavljanja kakovosti nad distribucijskimi operacijami, skladišči in poslovnimi partnerji v okviru dovoljenj Swissmedic.
- Vodenje zagotavljanja kakovosti za globalne in lokalne projekte dobavne verige ter zagotavljanje skladne in pravočasne izvedbe.
- Vodenje priprave na in podpora pri inšpekcijah zdravstvenih organov ter notranjih in zunanjih revizijah.
- Delovanje v vlogi globalnega strokovnjaka za dobro distribucijsko prakso (GDP) ter svetovanje deležnikom in zdravstvenim organom.
- Nadzorovanje obravnave odstopanj in pritožb, vključno s preiskavami, ocenjevanjem vpliva in pripravo odgovorov za stranke.
- Spodbujanje nenehnih izboljšav z upravljanjem tveganj, optimizacijo procesov in deljenjem pridobljenih izkušenj.
Vaš doprinos k delovnem mestu:
- Univerzitetna izobrazba s področja farmacije, kemije, biotehnologije ali sorodne naravoslovne vede.
- Več let izkušenj na področju zagotavljanja kakovosti v reguliranem farmacevtskem ali biofarmacevtskem okolju.
- Odlično poznavanje dobre proizvodne prakse (GMP), dobre distribucijske prakse (GDP) in sistemov vodenja kakovosti.
- Dokazane izkušnje z obvladovanjem odstopanj, preiskav, korektivnih in preventivnih ukrepov (CAPA) ter upravljanjem sprememb.
- Izkušnje z revizijami in inšpekcijami.
- Odlične komunikacijske sposobnosti.
- Izkušnje z ERP sistemom SAP (npr. ECC ali S/4HANA).
- Tekoče znanje angleškega jezika.
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.
Ugodnosti in nagrajevanje: Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, možnost vključitve v kolektivno zdravstveno zavarovanje, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju fizičnega in duševnega dobrega počutja ter delovne obremenitve (Polni življenja), številne priložnosti za učenje in razvoj.
Preberite naš priročnik, da spoznate načine, s katerimi bomo spodbujali vaš osebni in profesionalni razvoj: https://www.novartis.com/careers/benefits-rewards
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.
Zakaj Novartis: Pomagati bolnikom in njihovim družinam zahteva več kot le inovativno znanost. Potrebna je skupnost zavzetih ljudi, kot ste vi. V Novartisu cenimo sodelovanje, podporo in navdihovanje drug drugega za razvoj prebojnih terapij, ki spreminjajo življenja pacientov. Ste pripravljeni ustvariti svetlejšo prihodnost skupaj z nami? https://www.novartis.com/about/strategy/people-and-culture
Pridružite se Novartisu: Ni pravo delovno mesto za vas? Prijavite se v našo bazo talentov, da ostanete v kontaktu z nami in se seznanite z ustreznimi kariernimi priložnostmi takoj, ko se pojavijo: https://talentnetwork.novartis.com/network
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Key Responsibilities:
- Define and continuously evolve the global Supply Chain Management Quality Assurance strategy for Good Distribution Practices.
- Ensure end‑to‑end compliance with Good Manufacturing Practices, Good Distribution Practices, and regulatory requirements across distribution activities.
- Provide Quality Assurance oversight for distribution operations, warehouses, and trading partners within scope of Swissmedic licenses.
- Act as Quality Assurance lead for global and local Supply Chain projects, ensuring compliant and timely delivery.
- Lead preparation and support of Health Authority inspections and internal or external audits.
- Serve as global subject matter expert for Good Distribution Practices, advising stakeholders and Health Authorities.
- Oversee deviation and complaint management, including investigation, impact assessment, and customer responses.
- Drive continuous improvement through risk management, process optimization, and lessons‑learned sharing.
Essential Requirements:
- University degree in pharmacy, chemistry, biotechnology, or a related life science discipline.
- Several years of experience in quality assurance within a regulated pharmaceutical or biopharmaceutical environment.
- Strong knowledge of good manufacturing practice, good distribution practice, and quality management systems.
- Proven experience managing deviations, investigations, corrective and preventive actions, and change control.
- Experience with audits and inspections.
- Excellent communication skills.
- Experience with SAP ERP (such as ECC or S/4HANA).
- Fluent in English.
We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.
Benefits and Rewards: Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (Well-being), Unlimited learning and development opportunities.
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.
Read our handbook (PDF 30 MB)
VIDEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
