Head Biosimilar Technical Development (BTD) Quality (d/f/m)

Job Description Summary

The future is ours to shape. / Prihodnost je v naših rokah.

Job Description

As a Head Biosimilar Technical Development in Quality, you will be responsible for leading and managing the strategic and operational performance of the BTD Quality department, contributing to the successful delivery of the business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to Regulatory and Quality compliance including Sandoz Standards, international & local regulations to achieve success in development projects and ensure the efficient and effective day-to-day running of the Development Quality department.  You will be working in accordance with legislation, internal rules, good practices and business objectives.

Your key responsibilities:

• Responsibility for the definition, implementation and execution of the relevant Quality and Compliance strategy related to the Biosimilar projects (internal/external) to ensure uninterrupted development and subsequent supply of products. Therefore, is part of cross-functional teams to ensure alignment in the implementation of the Quality strategy E2E.
• Providing support and guidance to Biosimilar Technical Development (BTD) project teams to ensure quality output and handles compliance issues.
• Providing Quality governance in compliance with national and international GMP health authority requirements/standards.
• Owning and managing together with external partners quality related problems/matters for the assigned project portfolio to ensure they are resolved consistently and in accordance with relevant standards and policies.
• Ensuring, reviewing and approving of all quality related documents (specifications, validation protocols and reports, test instructions, method transfer documents, Quality by Design documentation, development reports).
• Managing/qualifying third party organizations/Alliance partners including establishment of Quality Assurance Agreements, audits and CAPA management.
• Supporting transfers from development to internal or external manufacturing sites/analytical CROs.
• Assuring consistency and reliability of the generated data in development.
• Providing QA support for preparation of submission documentation (dossier) and during deficiency letter phase.
• Ensuring compliance/QA oversight for all relevant BTD projects (internal and external).
• Supervising and harmonizing all quality related activities within BTD, ensuring compliance with systems and policies.
• Leading a group of associates, manages successful execution of Quality Assurance tasks in BTD, plans and aligns resources, strategies, activities, and processes to handle the given workload.
• Mentoring, coaching, and developing direct reports and manages/leads a high performing team that delivers continuous improvement and added value. Supporting a culture of quality, high performance, and trust.
• Other tasks determined during the annual objectives setting process and by KPIs.
• Other tasks as assigned by the supervisor and tasks based on a specific appointment.
• Providing conditions for and control of the implementation of HSE tasks and requirements in the unit.
• Communicating company vision and values; establish and manage good relationships with business partners.

What you will bring to the role:

• University degree in a pharmaceutical, chemistry, biology or other relevant field.
• Fluent in English.
• Knowledge of MS Office.
• Minimum 5 years of relevant working experience required within the pharmaceutical industry e.g. in Quality Assurance, Quality Control, Pharmaceutical Development, Production.

What we offer:

Job location: Ljubljana

Contract type: temporary contract for one (1) year with 6-month probation period

Expected weekly working hours: 40

*Pay range: €90,880 – €136,320 gross yearly

*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<I): 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 (the maximum annual amount is 3,224.18 EUR). 
• 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 September 22, 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.

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

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Vodja kakovosti v Razvoju podobnih bioloških zdravil Slovenija (d/ž/m)

Kot Vodja kakovosti v Razvoju podobnih bioloških zdravil Slovenija, boste odgovorni za vodenje in upravljanje strateške in operativne uspešnosti oddelka za kakovost v tehničnem razvoju biosimilarjev (BTD), s prispevkom k uspešni izvedbi poslovne strategije, ključnih kazalnikov uspešnosti (KPI) in ciljev, ob hkratnem zagotavljanju skladnosti z regulativnimi in kakovostnimi zahtevami, vključno s standardi Sandoza, mednarodnimi in lokalnimi predpisi, z namenom doseganja uspeha v razvojnih projektih ter učinkovitega in uspešnega vsakodnevnega delovanja oddelka za kakovost v razvoju. Delo bo v skladu z zakonodajo, internimi pravili, dobrimi praksami in poslovnimi cilji.

Vaše ključne odgovornosti:

• Odgovornost za opredelitev, implementacijo in izvajanje ustrezne strategije kakovosti in skladnosti, povezane z biosimilarnimi projekti (internimi/eksternimi), z namenom zagotavljanja nemotenega razvoja in kasnejše oskrbe s proizvodi. Zato je član večfunkcijskih timov, da se zagotovi usklajenost pri izvajanju strategije kakovosti od začetka do konca (E2E).
• Nudenje podpore in usmeritev projektnim timom za tehnični razvoj biosimilarjev (BTD), da se zagotovi kakovosten rezultat ter obravnava vprašanja skladnosti.
• Zagotavljanje upravljanja kakovosti v skladu z nacionalnimi in mednarodnimi zahtevami/standardi zdravstvenih organov GMP.
• Skupno lastništvo in upravljanje kakovostnih težav/zadev z zunanjimi partnerji za dodeljen portfelj projektov, da se zagotovi dosledna rešitev v skladu z ustreznimi standardi in politikami.
• Zagotavljanje, pregledovanje in odobravanje vseh dokumentov, povezanih s kakovostjo (specifikacije, validacijski protokoli in poročila, testna navodila, dokumenti o prenosu metod, dokumentacija Quality by Design, razvojna poročila).
• Upravljanje in kvalifikacija zunanjih organizacij/partnerskih zavezništev, vključno z vzpostavitvijo sporazumov o zagotavljanju kakovosti, izvedbo presoj in upravljanjem CAPA.
• Podpora pri prenosih iz razvoja na notranje ali zunanje proizvodne lokacije/analitične pogodbeno raziskovalne organizacije (CRO).
• Zagotavljanje doslednosti in zanesljivosti podatkov, pridobljenih med razvojem.
• Nudenje podpore QA pri pripravi dokumentacije za registracijo (dossier) in med fazo odgovarjanja na dopolnilna vprašanja.
• Zagotavljanje skladnosti in QA nadzora za vse relevantne BTD projekte (interne in eksterne).
• Nadzor in usklajevanje vseh aktivnosti, povezanih s kakovostjo znotraj BTD, ob zagotavljanju skladnosti s sistemi in politikami.
• Vodenje skupine sodelavcev, uspešno upravljanje izvajanja nalog zagotavljanja kakovosti v BTD, načrtovanje in usklajevanje virov, strategij, aktivnosti in procesov za obvladovanje obremenitev.
• Mentorstvo, coaching in razvoj neposredno podrejenih ter vodenje visoko zmogljive ekipe, ki zagotavlja stalne izboljšave in dodano vrednost. Podpora kulturi kakovosti, visoke učinkovitosti in zaupanja.
• Druge naloge, določene med letnim procesom postavljanja ciljev in na podlagi ključnih kazalnikov uspešnosti (KPI).
• Druge naloge po navodilu nadrejenega ali na podlagi posebnega imenovanja.
• Zagotavljanje pogojev za izvajanje nalog in zahtev HSE ter nadzor nad njihovo izvedbo v enoti.
• Komuniciranje vizije in vrednot podjetja; vzpostavljanje in upravljanje dobrih odnosov s poslovnimi partnerji.

Vaš prispevek k delovnemu mestu:

• Visokošolska strokovna izobrazba farmacije, kemije, biologije ali druge ustrezne smeri.
• Aktivno znanje angleškega jezika.
• Poznavanje orodja Microsoft Office.
• Minimalno 5 let delovnih izkušenj v farmacevtski industriji (v oddelku zagotavljanja kakovosti, farmacevtskem razvoju ali proizvodnji).

Kaj nudimo:

Lokacija dela: Ljubljana

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

Predvideni tedenski delovni čas: 40 ur

*Plačni razpon: 90.880 – 136.320 EUR bruto letno

*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<I): 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). 
• 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 22. septembra 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.

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

Skills Desired

Agility, Agility, Business Acumen, Business Partnering, Business Strategy, Clinical, Clinical Trials, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, Inspection Preparedness, Knowledge Of Gxp, Leadership, Organizational Savvy, People Management, Problem Solving Skill, Qa (Quality Assurance), Quality Management, Research, Risk Management, Root Cause Analysis (RCA) {+ 4 more}