Summary
Location: Ljubljana, Slovenia
Predstavljajte si, da igrate ključno vlogo pri tem, da življenjsko pomembna zdravila varno in skladno pridejo do bolnikov. Kot QA Operations Lead boste usmerjali ekipe, optimizirali procese in skrbeli za najvišje standarde kakovosti skozi razvoj, prenos in komercializacijo. Vaše vodenje bo oblikovalo operativno odličnost ter spodbujalo inovacije v dinamičnem, globalnem okolju.
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Imagine playing a pivotal role in ensuring life‑-changing medicines reach patients safely and compliantly. As QA Operations Lead, you’ll guide teams, optimize processes, and uphold the highest quality standards across development, transfer, and commercialization. Your leadership will shape operational excellence and drive innovation in a dynamic, global environment.
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:
- Zagotavljanje skladnosti vseh aktivnosti z veljavnimi standardi dobrih praks (cGxP).
- Vodenje in podpora pri GxP presojah ter inšpekcijskih pregledih regulatornih organov.
- Nadzor kakovostnih operacij na lokaciji, vključno z vhodnim in izhodnim QA.
- Pregled in odobritev glavnih proizvodnih zapisov (Master Batch Records, MBR).
- Upravljanje sproščanja izdelkov v skladu z globalnimi in lokalnimi predpisi.
- Vodenje QA aktivnosti za kontrolo kakovosti ter Analitične znanosti in tehnologijo (AS&T).
- Spodbujanje operativne odličnosti in kulture nenehnih izboljšav.
- Optimizacija procesov in učinkovito upravljanje operativnih stroškov QA enote.
Vaš doprinos k delovnem mestu:
- Univerzitetna izobrazba iz farmacije, biologije, kemije, mikrobiologije ali druge ustrezne naravoslovne oziroma tehniške smeri.
- Najmanj 5 let izkušenj na področju kakovosti, razvoja, proizvodnje ali primerljivih delovnih mest.
- Funkcionalno znanje angleškega jezika.
- Odlično poznavanje cGxP, EU/FDA regulative in mednarodnih standardov.
- Dokazane vodstvene sposobnosti ter izkušnje z razvojem ekip.
- Sposobnost vodenja presoj, inšpekcijskih pregledov in procesov sproščanja izdelkov.
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.
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:
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Key Responsibilities:
- Ensure all activities comply with current good practices (cGxP) standards.
- Lead and support GxP audits and regulatory inspections.
- Oversee Quality Operations across the site, including inbound and outbound QA.
- Review and approve Master Batch Records (MBR).
- Manage product release in line with global and local regulations.
- Drive QA for Quality Control and Analytical Science & Technology (AS&T).
- Champion operational excellence and continuous improvement initiatives.
- Optimize processes and manage QA operational unit costs effectively.
Essential Requirements:
- University degree in Pharmacy, Biology, Chemistry, Microbiology, or equivalent natural or engineering science.
- Minimum 5 years of experience in Quality, Development, Manufacturing, or comparable positions.
- Functional knowledge of English.
- Strong understanding of cGxP, EU/FDA regulations, and international standards.
- Demonstrated leadership and team development skills.
- Ability to manage audits, inspections, and product release processes.
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: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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.
Vodja upravljanja kakovosti - operacije (m/ž/d) / QA Operations Lead (m/f/d)
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