Ekspert upravljanja kakovosti ESO FDF (d/ž/m) / QA Manager ESO FDF (d/f/m)

Job Description Summary

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

Job Description

V naši ekipi zagotavljanja kakovosti za končne izdelke zunanjih dobaviteljev (QA ESO FDF) boste igrali ključno vlogo pri zagotavljanju, da naši partnerji delujejo skladno z najvišjimi standardi kakovosti. Skrbeli boste za usklajenost z globalnimi postopki, regulatornimi zahtevami in Sandozovim poslovnikom kakovosti ter aktivno prispevali k razvoju sistema kakovosti na lokalni ravni. Poleg tega boste uvajali nove sodelavce in sodelovali pri implementaciji najboljših praks na različnih lokacijah po svetu.

Vaše ključne odgovornosti:

• Vodi kvalifikacijo zunanjih dobaviteljev ter zagotavlja skladnost z zahtevami cGMP, pogodbo o kakovosti in lokalnimi postopki.
• Koordinira presoje dobaviteljev, upravlja letni program presoj ter skrbi za ustrezno izvedbo korektivnih in preventivnih ukrepov.
• Obravnava kritične težave glede kakovosti (odstopanja, reklamacije, odpoklice) ter zagotavlja ustrezno raziskavo in ukrepanje.
• Skrbi za veljavnost in vsebino pogodbe o kakovosti ter predlaga dopolnitve na podlagi ugotovljenih potreb.
• Sodeluje pri lansiranju izdelkov z oceno kakovosti, pripravo kontrolnih seznamov in usklajevanjem z različnimi funkcijami.
• Vzdržuje lokalni sistem kakovosti, uvaja globalne postopke ter usposablja nove sodelavce v oddelku kakovosti.
• Redno obvešča vodstvo o večjih težavah ter sodeluje pri strateških odločitvah in poročanju o uspešnosti dobaviteljev.
• Skrbi za osebni in strokovni razvoj ter upošteva varnostna in okoljska navodila v skladu z internimi politikami.

Vaš doprinos k delovnem mestu:

• Visokošolska izobrazba farmacevtske, kemijske ali druge primerne smeri.
• Tekoče znanje angleškega in slovenskega jezika.
• Poznavanje orodja MS Office.
• Zaželjene delovne izkušenje s področja upravljanja kakovosti, kontrole kakovosti, proizvodnje, regulative ali drugega primernega strokovnega področja.
• Vedoželjnost, dobro razvite komunikacijske veščine in hitro odzivanje na spremembe.

Kaj nudimo:

Lokacija dela: Ljubljana

Vrsta pogodbe: pogodba za določen čas 1 leta s 6-mesečnim poskusnim obdobjem

Predvideni tedenski delovni čas: 40

*Plačni razpon: 30.960–46.440 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 3. maj 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 within our QA ESO FDF team, you’ll be responsible for managing all aspects of quality related to external suppliers of pharmaceutical products and devices. You’ll ensure that operations are fully aligned with cGMP standards, regulatory requirements, the Quality Agreement, and the Sandoz Quality Manual. You’ll also play a key role in implementing global procedures across local sites and onboarding new team members, helping shape the future of quality excellence across borders.

Your key responsibilities:

Your responsibilities include, but not limited to:

• Lead the qualification process of external suppliers and ensure compliance with cGMP, the Quality Agreement, and local procedures.
• Coordinate and manage supplier audits, maintain the annual audit program, and ensure effective implementation of corrective and preventive actions.
• Handle critical quality issues (e.g. deviations, complaints, recalls) and ensure thorough investigations and appropriate resolution.
• Maintain and review the Quality Agreement, propose amendments based on identified needs, and ensure alignment with global standards.
• Support product launches through QA evaluations, checklist handovers, and coordination with cross-functional teams.
• Implement and maintain the local Quality System, introduce global procedures, and onboard new QA ESO FDF associates.
• Keep QA leadership and Supplier Relationship Manager informed of major quality concerns and contribute to strategic decision-making.
• Ensure continuous professional development and compliance with health, safety, and environmental requirements.

What you will bring to the role:

• University degree in pharmaceutical, chemical or other appropriate sciences.
• Experience in quality management, quality control, manufacturing, regulatory or other relevant professional field is a plus.
• Fluent knowledge of English and Slovene.
• Knowledge of Microsoft Office.
• Eagerness to learn, strong communication skills and the ability to adapt quickly to change.

What we offer:

Job location: Ljubljana

Contract type: temporary contract with 6-month probation period

Expected weekly working hours: 40

*Pay range: €30,960 – €46,440 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 May 3rd 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

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence