Ekspert upravljanja kakovosti ESO FDF I (d/ž/m) / QA Senior Manager ESO FDF (d/f/m)
Sandoz · Ljubljana · €45,120–€67,680 (stated in the posting)
Job Description Summary
Prihodnost je tu, oblikujmo jo skupaj. / The future is ours to shape.Job Description
V tej vlogi boste prevzeli odgovornost za zagotavljanje kakovosti zdravil in medicinskih pripomočkov, ki jih za Sandoz proizvajajo zunanji partnerji po svetu. Skrbeli boste za kakovostni nadzor nad ključnimi zunanjimi dobavitelji ter zagotavljali, da njihovo delo izpolnjuje zahteve dobrih proizvodnih praks (cGMP), regulatorne zahteve, dogovore o kakovosti in Sandozove standarde.
Gre za samostojno in odgovorno vlogo v mednarodnem okolju, kjer boste sodelovali z dobavitelji ter strokovnjaki iz različnih funkcij. Vodili boste kompleksne kakovostne primere, sodelovali pri pomembnih lansiranjih in projektih ter sprejemali strokovne odločitve, ki vplivajo na kakovost izdelkov, varnost bolnikov in zanesljivost dobave.
Vaše ključne odgovornosti:
- Samostojno upravljanje kakovosti pri ključnih zunanjih dobaviteljih farmacevtskih izdelkov in medicinskih pripomočkov.
- Zagotavljanje skladnosti dobaviteljev z zahtevami cGMP, regulatornimi zahtevami, dogovori o kakovosti, Sandozovimi standardi in ustreznimi postopki.
- Spremljanje kakovosti izdelkov, procesov in delovanja dobaviteljev ter priprava strokovnih ocen, poročil, kazalnikov uspešnosti in ocen tveganja.
- Vodenje zahtevnih kakovostnih preiskav, kritičnih odstopanj in eskalacij ter ocenjevanje njihovega možnega vpliva na izdelke, bolnike in regulatorne zahteve.
- Samostojno sprejemanje strokovnih odločitev v kompleksnih situacijah ter usklajevanje nadaljnjih aktivnosti z dobavitelji, vodstvom in drugimi notranjimi deležniki.
- Aktivno sodelovanje pri lansiranju novih izdelkov, sproščanju serij ter uvajanju globalnih zahtev, standardov in izboljšav.
- Sodelovanje z vodji odnosov z dobavitelji in drugimi funkcijami pri oblikovanju strategij, reševanju izzivov in zagotavljanju ustreznega delovanja dobaviteljev.
- Vodenje oziroma aktivno sodelovanje pri kompleksnih projektih in globalnih pobudah ter delovanje kot strokovni sogovornik za področje kakovosti zunanjih dobaviteljev.
Vaš prispevek k delovnemu mestu:
- Visokošolska izobrazba farmacevtske, kemijske ali druge ustrezne naravoslovne smeri.
- Najmanj 5 let relevantnih delovnih izkušenj na področju zagotavljanja kakovosti, kontrole kakovosti, farmacevtske proizvodnje, razvoja, regulative ali drugega primerljivega strokovnega področja.
- Zaželene so izkušnje na področju zagotavljanja kakovosti v GMP proizvodnem okolju ter dobro razumevanje farmacevtskih proizvodnih procesov.
- Sposobnost samostojnega vodenja kompleksnih aktivnosti, sprejemanja strokovnih odločitev in prevzemanja odgovornosti.
- Odločnost, samoiniciativnost ter sposobnost jasnega in učinkovitega sodelovanja z dobavitelji in različnimi deležniki v mednarodnem okolju.
- Tekoče znanje angleškega jezika.
Kaj nudimo:
Lokacija dela: Ljubljana
Vrsta pogodbe: pogodba za nedoločen čas s 6-mesečnim poskusnim obdobjem
Predvideni tedenski delovni čas: 40 ur
Plačni razpon (letna bruto plača): 45.120 – 67.680 EUR*
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 2026 je znašal 2.450,00 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 (zgornja zneskovna omejitev je 3.224,18 EUR letno).
- 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 25. 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
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In this role, you will take responsibility for ensuring the quality of medicines and medical devices manufactured for Sandoz by external partners around the world. You will oversee quality at key external suppliers and ensure that their work complies with current Good Manufacturing Practices (cGMP), regulatory requirements, Quality Agreements and Sandoz quality standards.
This is an independent and accountable role in an international environment, working closely with suppliers and cross-functional experts. You will lead complex quality cases, contribute to key launches and projects, and make sound quality decisions that impact product quality, patient safety and reliable supply.
Your key responsibilities:
- Independently manage quality oversight for key external suppliers of pharmaceutical products and medical devices.
- Ensure supplier compliance with cGMP, regulatory requirements, Quality Agreements, Sandoz quality standards and applicable procedures.
- Monitor product and process quality and supplier performance, and prepare expert assessments, reports, performance indicators and risk assessments.
- Lead complex quality investigations, critical deviations and escalations, assessing their potential impact on products, patients and regulatory requirements.
- Make independent quality decisions in complex situations and coordinate follow-up actions with suppliers, management and internal stakeholders.
- Actively contribute to new product launches, batch release activities and the implementation of global requirements, standards and improvements.
- Partner with Supplier Relationship Managers and other functions to shape strategies, address challenges and support effective supplier performance.
- Lead or actively contribute to complex projects and global initiatives, acting as a subject matter expert in external supplier quality.
What you will bring to the role:
- University degree in pharmaceutical, chemical or another relevant scientific discipline.
- At least 5 years of relevant experience in quality assurance, quality control, pharmaceutical manufacturing, development, regulatory affairs or a comparable professional field.
- Experience in quality assurance within a GMP manufacturing environment and a good understanding of pharmaceutical manufacturing processes are preferred.
- Ability to independently lead complex activities, make sound quality decisions and take accountability.
- Decisive and proactive approach, with the ability to communicate clearly and collaborate effectively with suppliers and diverse stakeholders in an international environment.
- Fluent English.
What we offer:
Job location: Ljubljana
Contract type: permanent contract with 6-month probation period
Expected weekly working hours: 40
Pay range (annual gross salary): € 45,120 – 67,680*
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 2026 it was €2,450.00 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
- 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 25 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