QA Manager ESO FDF II (d/f/m) / Ekspert upravljanja kakovosti ESO FDF II (d/ž/m)
Lek, a Sandoz companySlovenia7 hours ago
Full-timeRemote FriendlyQuality Assurance
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Job Description
As a QA Manager, you'll take on a dynamic and multifaceted role where no two days are the same. This position is perfect for someone who thrives in a positive team environment, enjoys cross-functional collaboration, and is eager to keep learning.
In this role, you'll lead quality oversight for external suppliers (Pharmaceuticals / Devices), ensuring full compliance with cGMP, regulatory standards, Quality Assurance Agreements, and the Sandoz Quality Manual – all while contributing to the success of vital healthcare products worldwide.
Your Key Responsibilities
Your responsibilities include, but not limited to:
Employment at the most reputable employer in Slovenia offers 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 (WellBeat), Unlimited learning and development opportunities.
Possible job locations: Slovenia (Ljubljana)
We offer a permanent contract with a 6-month probation period. You are kindly invited to submit your application in Slovene and English language, including CV, by 28. 10. 2025.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. While we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment To Diversity & Inclusion
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
#Sandoz
____________________________________________________________________________
V vlogi QA Managerja te čaka dinamično in raznoliko delo, kjer vsak dan prinese nove izzive. Iščemo osebo, ki se dobro počuti v spodbudnem timskem okolju, uživa v sodelovanju med različnimi oddelki in si želi nenehno nadgrajevati svoje znanje.
V tej vlogi boš odgovoren/-a za kakovostni nadzor zunanjih dobaviteljev (za farmacevtske izdelke in medicinske pripomočke) ter za zagotavljanje skladnosti z zahtevami cGMP, zakonodajo, dogovorjenimi standardi kakovosti in Sandozovim priročnikom kakovosti – vse to z mislijo na varnost in uspešnost ključnih izdelkov za zdravje bolnikov po svetu.
Vaše Ključne Odgovornosti
Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj.
Možne lokacije dela: Slovenija (Ljubljana)
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.
Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 28. 10. 2025 preko spletne povezave.
Zakaj Sandoz in Lek?
Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje 20.000 ljudi več kot 100 narodnosti. Na ta dosežek smo ponosni, a si želimo še več!
Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.
Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci ter sodelavke. V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero.
Prihodnost je v naših rokah!
Predani Smo Raznolikosti In Vključenosti
Sandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.
#Sandoz
As a QA Manager, you'll take on a dynamic and multifaceted role where no two days are the same. This position is perfect for someone who thrives in a positive team environment, enjoys cross-functional collaboration, and is eager to keep learning.
In this role, you'll lead quality oversight for external suppliers (Pharmaceuticals / Devices), ensuring full compliance with cGMP, regulatory standards, Quality Assurance Agreements, and the Sandoz Quality Manual – all while contributing to the success of vital healthcare products worldwide.
Your Key Responsibilities
Your responsibilities include, but not limited to:
- Ensure external suppliers provide annual product data or inspection results and contribute a critical evaluation of product and process performance, in line with quality agreements.
- Support product launches through QA assessments, quality checklists, inventory unit reviews, and cross-functional coordination.
- Implement and maintain the local quality system and procedures for external supplier management.
- Keep QA and Supplier Relations Managers informed of any major or critical issues that could impact product quality.
- Collaborate with the Supplier Relations Manager to provide guidance, develop strategies, and make decisions that ensure supplier performance.
- Contribute to QA reporting for external suppliers, including risk assessments, KPI tracking, and issue management.
- Maintain effective alignment with other Sandoz functions involved with external suppliers (e.g., Procurement, Legal, Supply Chain, Regulatory).
- Participate in projects and oversee implementation and monitoring of QA-related activities.
- University degree in pharmaceutical, chemical or other appropriate sciences.
- 1 year of experience in quality management, quality control, manufacturing, regulatory or other relevant professional field.
- Fluent knowledge of English and Slovene.
- Knowledge of Microsoft Office.
- Strong communication skills and the ability to adapt quickly to change.
Employment at the most reputable employer in Slovenia offers 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 (WellBeat), Unlimited learning and development opportunities.
Possible job locations: Slovenia (Ljubljana)
We offer a permanent contract with a 6-month probation period. You are kindly invited to submit your application in Slovene and English language, including CV, by 28. 10. 2025.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. While we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment To Diversity & Inclusion
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
#Sandoz
____________________________________________________________________________
V vlogi QA Managerja te čaka dinamično in raznoliko delo, kjer vsak dan prinese nove izzive. Iščemo osebo, ki se dobro počuti v spodbudnem timskem okolju, uživa v sodelovanju med različnimi oddelki in si želi nenehno nadgrajevati svoje znanje.
V tej vlogi boš odgovoren/-a za kakovostni nadzor zunanjih dobaviteljev (za farmacevtske izdelke in medicinske pripomočke) ter za zagotavljanje skladnosti z zahtevami cGMP, zakonodajo, dogovorjenimi standardi kakovosti in Sandozovim priročnikom kakovosti – vse to z mislijo na varnost in uspešnost ključnih izdelkov za zdravje bolnikov po svetu.
Vaše Ključne Odgovornosti
- Zagotavlja letno oceno izdelkov, procesov in uspešnosti zunanjih dobaviteljev v skladu s pogodbo o kakovosti ter vključuje te ocene v poročila.
- Podpira lansiranje izdelkov z oceno kakovosti, pripravo kontrolnih seznamov in usklajevanjem z različnimi funkcijami.
- Vzpostavlja, izvaja in vzdržuje lokalne postopke za upravljanje kakovosti zunanjih dobaviteljev.
- Skrbi za redno obveščanje vodje kakovosti in vodje odnosov z dobavitelji o vseh pomembnih težavah, ki bi lahko vplivale na kakovost.
- Skupaj z vodjem odnosov z dobavitelji sodeluje pri oblikovanju strategij in sprejemanju odločitev za učinkovito sodelovanje z dobavitelji.
- Poročanje o kakovosti vključuje oceno tveganja, KPI-je in spremljanje uspešnosti dobaviteljev.
- Vzdržuje povezave z drugimi funkcijami v Sandozu, kot so nabava, pravna služba, oskrba, regulatorne in kakovostne enote.
- Sodeluje pri projektih in skrbi za izvedbo vseh vidikov zagotavljanja kakovosti.
- Visokošolska izobrazba farmacevtske, kemijske ali druge primerne smeri.
- Tekoče znanje angleškega in slovenskega jezika.
- Poznavanje orodja MS Office.
- Eno leto delovnih izkušenj s področja upravljanja kakovosti, kontrole kakovosti, proizvodnje, regulative ali drugega primernega strokovnega področja.
- Komunikacijske veščine in hitro odzivanje na spremembe.
Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj.
Možne lokacije dela: Slovenija (Ljubljana)
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.
Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 28. 10. 2025 preko spletne povezave.
Zakaj Sandoz in Lek?
Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje 20.000 ljudi več kot 100 narodnosti. Na ta dosežek smo ponosni, a si želimo še več!
Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.
Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci ter sodelavke. V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero.
Prihodnost je v naših rokah!
Predani Smo Raznolikosti In Vključenosti
Sandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.
#Sandoz
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