Vodja skupine kontrole kakovosti

Job Description
Iščemo izkušenega in zavzetega strokovnjaka za vodenje oddelka za kontrolo kakovosti (QC), ki bo s strateškim pristopom in operativno odličnostjo zagotavljal visoke standarde kakovosti v proizvodnji učinkovin za podobna biološka zdravila.
V tej vlogi boš odgovoren/-na za nemoteno delovanje laboratorija, skladnost z regulativo (cGxP, GLP, EU, FDA), razvoj in vzdrževanje analitskih metod ter vodenje visoko usposobljene ekipe. Če te odlikujejo vodstvene sposobnosti, natančnost in strast do kakovosti, te vabimo, da se nam pridružiš pri soustvarjanju prihodnosti bioloških zdravil.

Kot
Vodja skupine kontrole kakovosti
boste odgovorni za vodenje in razvijanje kadrov ter procesov kontrole kakovosti oz. laboratorija, za nemoteno izvajanje kontrolnih aktivnosti s ciljem servisiranja kupcev, skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji.

Pridružite se nam pri soustvarjanju "novega" Sandoza in Leka
Vaše Ključne Odgovornosti

• Vodenje in strateški razvoj oddelka za kontrolo kakovosti (QC) z namenom zagotavljanja nemotenega vsakodnevnega delovanja ter skladnosti z zahtevami cGxP regulative.
• Nadzor nad izvajanjem analiz zdravilnih učinkovin v proizvodnji učinkovin za podobna biološka zdravila za zagotavljanje kakovosti in skladnosti z regulativnimi zahtevami.
• Zagotavljanje pravočasnega pregleda, potrditve in sprostitve analitskih podatkov ter laboratorijske dokumentacije.
• Skrb za skladnost z dobrimi laboratorijskimi praksami (GLP) ter zakonodajo Republike Slovenije, EU, FDA in drugimi relevantnimi regulatornimi organi; aktivna podpora pri notranjih in zunanjih presojah ter inšpekcijah.
• Vzdrževanje in posodabljanje analitskih metod, standardnih operativnih postopkov (SOP) in delovnih navodil v skladu s smernicami cGxP.
• Zagotavljanje kvalifikacije, kalibracije in rednega vzdrževanja laboratorijske opreme.
• Vodenje preiskav odstopanj, OOX rezultatov in reklamacij ter sodelovanje pri oblikovanju in izvajanju korektivnih in preventivnih ukrepov (CAPA).
• Spodbujanje kulture stalnih izboljšav in operativne odličnosti znotraj QC oddelka.
• Upravljanje usposabljanj, spremljanje učinkovitosti ter strokovni razvoj članov ekipe v skladu z zahtevami cGxP.
• Krepitev medoddelčnega sodelovanja ter spodbujanje kulture kakovosti, varnosti in skladnosti v celotni organizaciji.

Vaš Doprinos k Delovnem Mestu

• Visokošolska stopnja izobrazbe farmacevtske, biološke, kemijske, mikorbiološke ali druge naravoslovne smeri.
• Minimalno 3 leta delovnih izkušenj na področju laboratorijskih procesov ali podobnih pozicij.
• Aktivno znanje angleškega jezika (ustno in pisno).

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 (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj.

Lokacija 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
____________________________________________________________________________________________

We are looking for an experienced and dedicated professional to lead our Quality Control (QC) department, ensuring operational excellence and regulatory compliance in the production of active pharmaceutical ingredients for biosimilars.
In this strategic role, you will be responsible for the smooth daily operation of the QC lab, adherence to cGxP, GLP, EU, and FDA regulations, development and maintenance of analytical methods, and leadership of a skilled team. If you are a detail-oriented leader with a passion for quality, we invite you to join us in shaping the future of biopharmaceuticals.

As
Quality Team Leader QC
you will be responsible for leading and developing both the team and the quality control (QC) processes or laboratory operations. Your main goal will be to ensure the smooth execution of control activities in line with customer needs, applicable legislation, internal procedures, good practices, and overall business objectives.

Join us as a Founder of our 'new' Sandoz and Lek
Your Key Responsibilities
Your responsibilities include, but not limited to:

• Leading and strategically developing the Quality Control (QC) department to ensure smooth daily operations and compliance with cGxP regulatory requirements.
• Overseeing the execution of active pharmaceutical ingredient (API) analyses for biosimilars to ensure product quality and regulatory compliance.
• Ensuring timely review, approval, and release of analytical data and laboratory documentation.
• Ensuring compliance with Good Laboratory Practices (GLP) and the legislation of the Republic of Slovenia, EU, FDA, and other relevant regulatory bodies; actively supporting internal and external audits and inspections.
• Maintaining and updating analytical methods, standard operating procedures (SOPs), and work instructions in accordance with cGxP guidelines.
• Ensuring qualification, calibration, and regular maintenance of laboratory equipment.
• Leading investigations of deviations, OOX results, and complaints, and contributing to the development and implementation of corrective and preventive actions (CAPA).
• Promoting a culture of continuous improvement and operational excellence within the QC department.
• Managing training, monitoring performance, and supporting the professional development of team members in line with cGxP requirements.
• Strengthening cross-functional collaboration and fostering a culture of quality, safety, and compliance across the organization.

What You Will Bring To The Role

• University degree in Pharmacy, Biology, Chemistry, Microbiology, or another related natural science field.
• Minimum of 3 years of professional experience in laboratory processes or in a comparable position.
• Proficient command of English, both 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 (WellBeat), Unlimited learning and development opportunities.

Job location:
Lendava, Slovenia
We offer
permanent contract with 6-month 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