Vodja zagotavljanja skladnosti kakovosti (m/ž/d) / Head Compliance (m/f/d)

SummaryLokacija: Ljubljana, SlovenijaPodpora pri selitvi: Ta vloga ima sedež v Ljubljani, Slovenija. Novartis ne nudi podpore pri selitvi: prijavite se le, če je za vas dostopno.Kot Vodja skladnosti (m/ž/d) boste imeli osrednjo vlogo pri oblikovanju in vzdrževanju sistemov kakovosti ter zagotavljanju skladnosti z mednarodnimi standardi. Med vaše naloge bo sodilo vodenje revizij in inšpekcijskih postopkov, podpora razvoju ekipe ter izboljšava procesov poročanja o kakovosti. Položaj združuje vodstveni pristop, timsko sodelovanje in jasno usmerjenost k doseganju ciljev.Če vas motivira delo v skladu s predpisi in želite prispevati k strokovni rasti ekipe, je to lahko vaš naslednji odličen korak v karieri.________________________Location: Ljubljana, SloveniaRelocation Support: This role is based in Ljubljana, Slovenia. Novartis is unable to offer relocation support: please only apply if accessible.Looking to make a real impact while leading with confidence? As Head Compliance, you’ll play a key role in shaping quality systems and ensuring regulatory excellence across global standards. From guiding audits and inspections to supporting team development and driving improvements in quality reporting, this role offers a dynamic mix of leadership, collaboration, and purpose. If you’re passionate about doing things right and helping others grow, this could be your next great move.About The RoleVaše ključne odgovornosti:Vodenje in upravljanje virov za kakovost in skladnost.Razvoj, izvajanje in nadzor sistema kakovosti za zagotavljanje skladnosti z regulativnimi zahtevami (Slovenija, EU, FDA, ICH, PIC).Priprava in odobritev notranjih standardnih operativnih postopkov.Izvajanje notranjih revizij in revizij zunanjih izvajalcev.Vodenje inšpekcijskih pregledov in revizij s strani strank.Podpora razvoju informacijskih sistemov za upravljanje kakovosti in poročanje.Zagotavljanje skladnosti pri obravnavi reklamacij pritožb in odstopov odstopanj v fazi distribucije izdelkov.Upravljanje kakovosti na področju laboratorijev, Globalne QC/AS&T, T&L skupine, kot tudi projektov novih stavb in predelav ter skladišč.Vaš Doprinos k Delovnem MestuNajmanj 10 let izkušenj na področju kakovosti, razvoja ali proizvodnje.Visokošolska stopnja izobrazbe iz farmacije, kemije ali drugih naravoslovnih ved.Funkcionalno znanje angleščine za strokovno komunikacijo.Dobro poznavanje globalnih regulativnih standardov (Slovenija, EU, FDA, ICH, PIC).Dokazane sposobnosti vodenja presoj revizij, inšpekcij in inciativ glede skladnosti.Izkušnje z razvojem in upravljanjem sistemov kakovosti ter SOP-jev.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, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in fizičnega počutja (iniciativa 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-rewardsZakaj 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-culturePridružite 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/networkPredani 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.Dostop in prilagoditve: V Novartisu si prizadevamo k vključenosti oseb z invalidnostjo in zagotavljanju ustreznih prilagoditev delovnega okolja posameznikom z omejitvami. V kolikor zaradi bolezni ali invalidnosti potrebujete ustrezne prilagoditve v kateremkoli delu selekcijskega procesa oziroma potrebujete prilagoditve pri izvajanju osnovnih nalog na delovnem mestu, nam pišite na naslov diversity.inclusion_slo@novartis.com in navedite, kakšne prilagoditve potrebujete ter vaše kontaktne podatke. Prosimo, vključite tudi podatek o številki razpisa, na katerega se prijavljate.________________________Key ResponsibilitiesLeadership and management of resources.Development, implementation and supervision of the quality system to ensure regulatory compliance (Slovenian, EU, FDA, ICH, PIC).Creation and approval of internal standard operating procedures.Performing internal audits and external contractor audits.Leading customer inspections and audits.Supporting development of quality information systems and reporting.Ensuring regulatory compliance in complaint and deviation handling during product distribution.Providing QA Compliance Oversight to Laboratory Operations (specifically QLS), Global QC/AST team whenever it is needed, T&L group as well as over project of new premises and warehouses.Essential RequirementsMinimum 10 years of experience in quality, development, or production.University-level degree in pharmacy, chemistry, or equivalent natural sciences.Functional knowledge of English for professional communication.Strong understanding of global regulatory standards (Slovenian, EU, FDA, ICH, PIC).Proven ability to lead audits, inspections, and compliance initiatives.Experience in developing and managing quality systems and SOPs.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, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (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.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 diversity.inclusion_slo@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.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-cultureJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkBenefits 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