Vodja upravljanja kakovosti - operacije (m/ž/d) / QA Operations Lead (m/f/d) job opportunity at Novartis.



DateMore Than 30 Days Ago bot
Novartis Vodja upravljanja kakovosti - operacije (m/ž/d) / QA Operations Lead (m/f/d)
Experience: 5-years
Pattern: full-time
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degreeMaster's (M.A.)
loacation Ljubljana, Slovenia
loacation Ljubljana....Slovenia

Job Description Summary #LI-Hybrid 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. ------------------------------- 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.   Job Description 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 : ------------------------------------------ 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   (We ll-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.     Skills Desired Audit Management, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management, People Management and Leadership, Product Release, Qa (Quality Assurance), Self-Awareness, Technological Expertise

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