Vodja projekta za zagotavljanje kakovosti (d/ž/m) / Project Quality Manager (d/f/m)

Job Description Summary

Prihodnost je tu, oblikujmo jo skupaj. / The future is ours to shape.

Job Description

V Leku na ljubljanski lokaciji gradimo enega največjih in tehnološko najbolj naprednih biofarmacevtskih centrov za razvoj in proizvodnjo kliničnih in komercialnih serij bioloških učinkovin. Projekt temelji na najsodobnejši biofarmacevtski tehnologiji in predstavlja pomemben del globalne strategije Sandoza za razvoj in proizvodnjo podobnih bioloških zdravil. V tem centru bodo nastajali izdelki, ki z naprednimi procesi in inovativnimi pristopi pomembno prispevajo k izboljšanju kakovosti življenja pacientov po svetu ter uresničujejo naše poslanstvo zagotavljati kakovostna in dostopna zdravila.

Kot vodja projekta za zagotavljanje kakovosti na področju objektov in opreme boste usmerjali in nadzorovali aktivnosti načrtovanja, kvalifikacije in zagona objekta, procesne opreme ter podpornih sistemov. Vaša vloga bo ključna za uspešno vzpostavitev, zagon in delovanje najsodobnejšega obrata za proizvodnjo bioloških učinkovin.

Vaše ključne odgovornosti:

 

Vodenje aktivnosti za zagotavljanje kakovosti za objekt, procesno opremo in podporne sisteme skozi celoten življenjski cikel projekta, od načrtovanja do GMP zagona.

Pregledovanje in odobravanje projektne dokumentacije ter zagotavljanje, da so projektne rešitve primerne za predvideno uporabo in skladne z GMP ter regulatornimi zahtevami.

Sodelovanje pri zagonskih aktivnostih, vključno s FAT (Factory Acceptance Testing) in SAT (Site Acceptance Testing) ter zagotavljanje pravočasne odprave ugotovljenih pomanjkljivosti.

Pregledovanje in odobravanje kvalifikacijske dokumentacije (DQ – design qualification, IQ - Installation Qualification, OQ - Operational Qualification) ter spremljanje poteka in uspešnosti kvalifikacijskih aktivnosti.

Zagotavljanje učinkovitega upravljanja tveganj s pomočjo FRA (Functional Risk Assessment), SRA (Sensor Risk Assessment), ocene alarmov in drugih ocen tveganj za podporo sprejemanju ustreznih.

Nadzor nad obvladovanjem projektnih odstopov in sprememb ter zagotavljanje njihove pravočasne in ustrezne obravnave.

Vodenje priprav na inšpekcije ter zagotavljanje uspešnih zagovorov pred regulatornimi organi in drugimi presojevalci.

Sodelovanje z inženiringom, proizvodnjo, MS&T in drugimi ključnimi deležniki za zagotovitev uspešne vzpostavitve in delovanju novega obrata za proizvodnjo bioloških učinkovin.

Vaš prispevek k delovnemu mestu:

Minimalno 10 let delovnih izkušenj na področju kakovosti ali proizvodnje v farmacevtski industriji.

Visokošolska stopnja izobrazba strojne, farmacevtske, kemijske, ali druge ustrezne tehnične ali naravoslovne smeri.

Tekoče znanje slovenskega in angleškega jezika.

Izkušnje z inšpekcijami.

Izkušnje z delom na projektih v farmacevtski industriji.

Kaj nudimo:

Lokacija dela: Ljubljana

Vrsta pogodbe: pogodba za nedoločen čas s 6-mesečnim poskusnim obdobjem

Predvideni tedenski delovni čas: 40

*Plačni razpon: 58.080–87.120 EUR bruto

* Plača v Sandozu temelji na nivoju delovnega mesta, kvalifikacijah, specifičnih veščinah in znanjih ter delovnih izkušnjah. Visoko usposobljeni kandidati so običajno umeščeni okoli mediane plačnega razpona, manj izkušeni na spodnji del razpona, kandidati z izrazito močnimi ali nišnimi kompetencami pa višje. Pri umeščanju v plačni razpon upoštevamo tudi notranjo uravnoteženost plač in zunanje tržne podatke .

Naš paket ugodnosti dodatno vključuje:

Letni bonus (STI): odstotek letne plače

Regres za letni dopust: leta 2025 je znašal 2.430,99 EUR (neto)

Božičnica: leta 2025 je znašala 2.100 EUR (bruto)

OurShare: Vsako leto bo zaposleni v družbi Lek d.d. upravičen do prejema delnic družbe Sandoz AG

Prostovoljno dodatno pokojninsko zavarovanje: družba Lek d.d. v celoti krije mesečni prispevek za dodatno pokojninsko zavarovanje v višini 5,844 % vaše mesečne bruto plače

Dodatek za izmensko delo (15 %); turnusno delo (20 %), nočno delo (70 %), delo ob nedeljah in praznikih (50 %), nadurno delo (30 %) – če to velja za zadevno delovno mesto

Kolektivno življenjsko in nezgodno zavarovanje (kritje velja 24/7)

Hibridno delovno okolje, ki omogoča fleksibilnost in možnost dela na daljavo. – če to velja za zadevno delovno mesto

Ste pripravljeni na naslednji korak v karieri?

Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do 30. oktober 2026.

 

Zakaj Sandoz?

Sandoz je vodilni svetovni proizvajalec generičnih in podobnih bioloških zdravil – segmenta zdravstvene industrije, ki zagotavlja 80 % vseh zdravil na svetu po 30-odstotni ceni ter s tem vpliva na življenja več kot milijarde ljudi v več kot 100 državah. Čeprav smo ponosni na svoje dosežke, si prizadevamo narediti še več, da bi vsakdo imel dostop do temeljne človekove pravice – pravice do dobrega zdravja.

Z naložbami v nove razvojne zmogljivosti, proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza ter še večjemu številu ljudi omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.

Naš zagon temelji na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci in sodelavke. V okolju, kjer so raznoliki načini razmišljanja dobrodošli in kjer se podpira osebna rast, imajo v zameno za uporabo svojih znanj možnost v celoti izkusiti delo v agilnem in povezovalnem okolju ter razvijati svojo uspešno kariero.

Pridružite se nam in nam pomagajte povečati pravičnost in hitrost zdravstvenega varstva.

Prihodnost je v naših rokah.

Predani smo raznolikosti in vključenosti:

Zavzemamo se za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.

#Sandoz

____________________________________________________________

At the Lek’s Ljubljana site, we are building one of the largest and most technologically advanced biopharmaceutical centers for the development and production of clinical and commercial batches in Slovenia. The project is based on state‑of‑the‑art biopharmaceutical technology and represents an important part of Sandoz’s global strategy for the development and manufacturing of biosimilar medicines. In this center, products will be created using advanced processes and innovative approaches, significantly contributing to improving the quality of life for patients around the world and fulfilling our mission to provide high‑quality and accessible medicines.

As a Project Quality Manager – Facility & Equipment, you will provide quality leadership and oversight for facility, utility and process equipment design, qualification and GMP readiness. You will play a key role in bringing a state-of-the-art biologic drug substance production facility into operation.

Your key responsibilities:

Lead QA activities for the new facility, process equipment and utility systems throughout the project lifecycle, from design to GMP start-up and in operation.

Review and approval of project documentation to ensure compliance with GMP and regulatory requirements.

Support commissioning activities, including FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) and ensure timely resolution of identified issues.

Review and approval qualification documentation (DQ-Design Qualification, IQ - Installation Qualification, OQ - Operational Qualification) and monitor progress and completion of qualification activities.

Lead risk management activities: FRA (Functional Risk Assessment), SRA (Sensor Risk Assessment), alarms assessments and other risk assessments to support right project solutions and decisions.

Oversight of project deviations and changes, ensuring proper assessment, implementation of corrective and preventive measures and timely closure.

Lead inspection readiness activities and support successful outcomes of health authorities’ inspections and other audits.

Collaboration with Engineering, Manufacturing, MS&T and other stakeholders to ensure the successful start-up and operation of a new biologic drug substance production facility.

What you will bring to the role:

At least 10 years of experience in quality or manufacturing within the pharmaceutical industry

University degree in mechanical engineering, pharmacy, chemistry, or another relevant technical or natural sciences field

Fluency in Slovenian and English

Experience with inspections

Experience working on projects in the pharmaceutical industry

What we offer:

Job location: Ljubljana

Contract type: Permanent contract with 6-month probation period

Expected weekly working hours: 40

*Pay range: €58,080 – €87,120 gross

* Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data.

Our compensation package additionally includes:

Annual bonus (STI): percentage of annual salary

Vacation allowance: in 2025 it was €2,430.99 net

Christmas bonus: in 2025 it was €2,100 gross

OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG

Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary

Allowance for shift work (15%); rotational shifts (20%), night shift work (70%), Sunday/public holiday work (50%), overtime work (30%) – if applicable for position

Collective life and accident insurance (24/7 coverage)

A hybrid work environment offering flexibility and remote work possibilities – if applicable for position

Ready for your next career move?

You are kindly invited to submit your application in English and Slovene, including a CV, by 30 October 2026.

 

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have the ambition to do more so that everyone can benefit from the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions and partnerships, we have the opportunity to shape a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines.

Our momentum 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 where diversity of thought is welcomed and where personal growth is supported!

Join us in helping to make healthcare fairer and faster.

The future is ours to shape.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and to forming diverse teams that are representative of the patients and communities we serve.

#Sandoz

Skills Desired