Vodja skupine AS&T

Job Description Summary

Job Description

Pridruži se naši ekipi v Visokotehnološkem centru za proizvodnjo učinkovin za podobna biološka zdravila v Lendavi in prevzemi strateško vodilno vlogo pri upravljanju analitskih aktivnosti. Skrbel/-a boš za skladnost z regulativo, znanstveno odličnost ter pravočasno izvedbo nalog. Iščemo strokovnjaka/-injo, ki združuje tehnično znanje z močnimi vodstvenimi sposobnostmi ter spodbuja inovacije in nenehne izboljšave.

Kot Vodja skupine AS&T boste odgovorni za operativno vodenje določenega področja / laboratorija v enoti Analitske znanosti in tehnologije (AS&T) in zagotavljanje skladnosti z vsemi trenutnimi dobrimi praksami, regulativnimi in ZVO (zdravje, varnost, okolje) vidiki ter odgovornost za vodenje ljudi znotraj svoje pristojnosti.

Pridružite se nam pri soustvarjanju "novega" Sandoza in Leka

Vaše ključne odgovornosti:

• Strateško vodenje in nadzor nad vsemi analitskimi aktivnostmi v okviru dodeljenih projektov, skladno s cilji projektov ter veljavnimi regulativnimi zahtevami.
• Načrtovanje, vodenje in usklajevanje pravočasnega prenosa analitskih metod ter validacij v okviru uvedbe novih izdelkov in tehnoloških prenosov.
• Upravljanje življenjskega cikla analitskih metod s poudarkom na stalnih izboljšavah, skladnosti, robustnosti in znanstveni utemeljenosti.
• Načrtovanje, izvajanje in nadzor stabilnostnih študij za zagotavljanje dolgoročne kakovosti izdelkov ter skladnosti z zakonodajo in smernicami regulatornih organov.
• Delovanje kot primarna kontaktna oseba za interne projektne time, zunanje partnerje ter pogodbeno določene laboratorije.
• Nudenje strokovne podpore oddelkom za kontrolo kakovosti, proizvodnjo in regulativne zadeve, vključno s pripravo in oddajo dokumentacije.
• Zagotavljanje skladnosti z dobrimi laboratorijskimi praksami (GLP) ter izvajanje aktivnosti v skladu z nacionalno zakonodajo, evropskimi smernicami in zahtevami FDA; aktivna podpora med internimi in zunanjimi presojami ter inšpekcijskimi nadzori.
• Usklajevanje operativnih aktivnosti oddelka z namenom doseganja učinkovitosti, kakovosti in skladnosti.
• Odgovornost za linije in dnevne preglede (obhode) v skladu z internimi standardi.

Vaš doprinos k delovnem mestu:

• Univerzitetna izobrazba iz farmacije, kemije, biotehnologije ali sorodnega področja.
• Najmanj 3 leta izkušenj na področju analitskih laboratorijskih procesov ali na podobni poziciji.
• Odlično poznavanje zahtev cGxP in GLP.
• Izkušnje s prenosom metod, validacijo in stabilnostnimi študijami.
• Vodstvene sposobnosti in zmožnost vodenja večdisciplinarnih ekip.
• Odlično razumevanje regulatornih zahtev (EU, FDA) ter izkušnje z inšpekcijami in presojami.
• Analitičen način razmišljanja, proaktivnost in usmerjenost k reševanju problemov.
• Zelo dobro znanje angleškega jezika (pisno in ustno).

Kaj nudimo:

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. 

Lokacije dela: Lendava, Slovenija

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 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 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.  

#BIORampUp #Sandoz

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Join our team and take a strategic leadership role in managing analytical activities across assigned projects, ensuring compliance, scientific excellence, and timely execution. We are looking for someone who combines technical expertise with strong leadership capabilities to drive innovation and continuous improvement.

As Quality Team Leader AS&T (d/f/m), you will be responsible for the operational management of a specific area/laboratory within the Analytical Science & Technology (AS&T) unit, ensuring compliance with all current good practices, regulatory requirements, and HSE (Health, Safety, Environment) aspects, as well as for leading people within your scope of responsibility.

Be part of shaping the "new" Sandoz and Lek

Your key responsibilities:

Your responsibilities include, but not limited to:

• Strategic leadership and oversight of all analytical activities within assigned projects, ensuring alignment with project goals and regulatory requirements.
• Planning, leading, and coordinating timely execution of analytical method transfers and validations for new product introductions and technology transfers.
• Managing the lifecycle of analytical methods, with a focus on continuous improvement, compliance, robustness, and scientific justification.
• Designing, executing, and supervising stability studies to ensure long-term product quality and compliance with regulatory guidelines.
• Acting as the primary point of contact for internal project teams, external partners, and contract laboratories.
• Providing scientific support to Quality Control, Manufacturing, and Regulatory Affairs, including assistance with documentation preparation and submission.
• Ensuring compliance with Good Laboratory Practices (GLP) and activities aligned with national legislation, EU guidelines, and FDA requirements; actively supporting internal and external audits and inspections.
• Coordinating operational activities within the department to achieve efficiency, quality, and compliance.
• Responsibility for production lines and daily walkthroughs in accordance with internal standards.

What you will bring to the role:

• University degree in Pharmacy, Chemistry, Biotechnology, or a related field.
• Minimum of 3 years of experience in analytical laboratory processes or similar roles.
• Strong knowledge of cGxP and GLP requirements.
• Experience in method transfer, validation, and stability studies.
• Leadership skills and ability to manage cross-functional teams.
• Excellent understanding of regulatory requirements (EU, FDA) and experience with audits.
• Analytical mindset, proactive approach, and problem-solving orientation.
• Very good command of English (written and spoken).

You'll receive:

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. 

Job location: Lendava, Slovenia  

We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by November 30th, 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. 

#BIORampUp #Sandoz

Skills Desired