QA Senior Manager Biosimilars (d/f/m) / Višji ekspert upravljanja kakovosti I Podobna biološka zdravila (d/ž/m)
Lek, a Sandoz companySlovenia16 hours ago
Full-timeRemote FriendlyQuality Assurance
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Job Description
30+ is the current number of planned projects in the Development of Biosimilar medicine for the treatment of cancer, autoimmune diseases, diabetes and others. If you are interested in working in a dynamic, interdisciplinary and international environment and if you are interested in making sure our products meet high quality standards, join us.
As QA Senior Manager Biosimilars (d/f/m) you will be responsible for designing and ensuring compliance of the internal quality system. Your focus will be on reducing risks related to product and substance quality, as well as minimizing the cost of poor quality – all in line with regulatory requirements, internal standards, best practices, and business objectives. You will also be responsible for developing and transferring expert knowledge in the field of quality, actively contributing to continuous process improvement.
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 (Energized for Life), Unlimited learning and development opportunities.
Possible job locations: Slovenia (Ljubljana)
We offer permanent contract with 6-month of probation period.
You are kindly invited to submit your application in English language, including CV, by 17.11.2025
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and 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 #BioRampUp
- - - - - - - - - -
30+ je trenutno število planiranih projektov v Razvoju podobnih bioloških zdravil za zdravljenje rakavih obolenj, avtoimunih bolezni, diabetesa in drugih. Če te zanima delo v dinamičnem, interdisciplinarnem ter mednarodnem okolju in če te zanima skrb za najvišjo kakovost naših izdelkov, se nam pridruži.
Kot Višji ekspert upravljanja kakovosti I Podobna biološka zdravila (d/ž/m) boste odgovorni za oblikovanje in zagotavljaneu skladnosti internega sistema kakovosti. Vaš cilj bo zmanjševanje tveganj, povezanih s kakovostjo izdelkov in učinkovin, ter zniževanje stroškov slabe kakovosti – vse skladno z zakonodajo, internimi smernicami, dobrimi praksami in poslovnimi cilji. Poleg tega boste odgovorni za razvoj in prenos strokovnega znanja s področja kakovosti ter aktivno prispevali k nenehnemu izboljševanju procesov.
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 (Polni življenja) 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 17.11.2025 preko spletne povezave.
Zakaj Sandoz in Lek?
Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Sandoz se je kot vodilni v tem sektorju lani dotaknil življenj skoraj 500 milijonov bolnikov. 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 in 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 #BioRampUp
30+ is the current number of planned projects in the Development of Biosimilar medicine for the treatment of cancer, autoimmune diseases, diabetes and others. If you are interested in working in a dynamic, interdisciplinary and international environment and if you are interested in making sure our products meet high quality standards, join us.
As QA Senior Manager Biosimilars (d/f/m) you will be responsible for designing and ensuring compliance of the internal quality system. Your focus will be on reducing risks related to product and substance quality, as well as minimizing the cost of poor quality – all in line with regulatory requirements, internal standards, best practices, and business objectives. You will also be responsible for developing and transferring expert knowledge in the field of quality, actively contributing to continuous process improvement.
Your Key Responsibilities
Your responsibilities include, but not limited to:
- Responsible for the development of an internal quality system for Biosimilar Development projects and ensuring Quality compliance as per pharmaceutical regulations, good pharmaceutical practice and Sandoz requirements e.g.internal procedures and as defined in Quality Assurance Agreements with external partners (QAAs).
- Review of documentation and responsibility for giving quality guidance based on regulations and standards but give room for scientific and technical discussions.
- Responsibility for ensuring timely achievement of project Quality deliverables (including quality assessment, deviations, CAPA, escalations, changes, approval of documents, etc.).
- Negotiation of Quality Assurance Agreements (QAA) with external partners.
- Change and deviation management, complaint handling.
- Escalate risks and issues, as well as propose mitigating actions.
- Contribute to process simplification and QMS improvements.
- University degree in Microbiology, Biotechnology, Biochemistry or equivalent.
- Minimum 5 years of working experience in Biopharma quality/quality assurance or operations (i.e. Upstream / Downstream process development, Drug product development, analytics).
- Excellent communication and organizational skills.
- Excellent skills in identifying issues and solving problems.
- Excellent & detailed knowledge of GMP-regulations.
- Fluent in English.
- Knowledge of Microsoft Office.
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 (Energized for Life), Unlimited learning and development opportunities.
Possible job locations: Slovenia (Ljubljana)
We offer permanent contract with 6-month of probation period.
You are kindly invited to submit your application in English language, including CV, by 17.11.2025
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and 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 #BioRampUp
- - - - - - - - - -
30+ je trenutno število planiranih projektov v Razvoju podobnih bioloških zdravil za zdravljenje rakavih obolenj, avtoimunih bolezni, diabetesa in drugih. Če te zanima delo v dinamičnem, interdisciplinarnem ter mednarodnem okolju in če te zanima skrb za najvišjo kakovost naših izdelkov, se nam pridruži.
Kot Višji ekspert upravljanja kakovosti I Podobna biološka zdravila (d/ž/m) boste odgovorni za oblikovanje in zagotavljaneu skladnosti internega sistema kakovosti. Vaš cilj bo zmanjševanje tveganj, povezanih s kakovostjo izdelkov in učinkovin, ter zniževanje stroškov slabe kakovosti – vse skladno z zakonodajo, internimi smernicami, dobrimi praksami in poslovnimi cilji. Poleg tega boste odgovorni za razvoj in prenos strokovnega znanja s področja kakovosti ter aktivno prispevali k nenehnemu izboljševanju procesov.
Vaše Ključne Odgovornosti
- Zagotavljanje kakovosti in skladnosti v skladu z regulativnimi zahtevami in zahtevami Sandoza, npr. opredeljeno v sporazumih o zagotavljanju kakovosti (QAA).
- Pregled dokumentacije in dajanje smernic na podlagi predpisov in standardov ter omogočanje znanstvenih in tehničnih razprav.
- Zagotavljanje pravočasnega doseganja rezultatov projekta na področju kakovosti (vključno z ocenami kakovosti, vodenje odstopov, CAPA, eskalacij, sprememb, potrjevanje dokumentov, itd).
- Pogajanje o sporazumih o zagotavljanju kakovosti (angl. QAA) z zunanjimi partnerji.
- Upravljanje sprememb in odstopanj ter reševanje pritožb.
- Opozarjati na tveganja in težave ter predlagati ukrepe za njihovo omilitev.
- Sodelovanje pri poenostavitvi procesov in izboljšavah sistema vodenja kakovosti (angl. QMS).
- Univerzitetna izobrazba s področja mikrobiologije, biotehnologije, biokemije ali sorodno področje.
- Najmanj 5 let delovnih izkušenj na področju kakovosti / zagotavljanja kakovosti ali operacij na področju podobnih bioloških zdravil v farmacevtski industriji (npr. celične banke, razvoj / proizvodnja podobnih bioloških aktivnih učinkovin ali končnih izdelkov, analitika).
- Odlične komunikacijske in organizacijske spretnosti.
- Odlične sposobnosti prepoznavanja težav in reševanja problemov.
- Odlično in podrobno poznavanje predpisov o dobri proizvodni praksi (angl. GMP).
- Tekoče znanje angleškega jezika.
- Poznavanje programa Microsoft Office.
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 (Polni življenja) 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 17.11.2025 preko spletne povezave.
Zakaj Sandoz in Lek?
Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Sandoz se je kot vodilni v tem sektorju lani dotaknil življenj skoraj 500 milijonov bolnikov. 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 in 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 #BioRampUp
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