Job Description

Salary Range:

39.270,00 € - 72.930,00 €#LI-Hybrid
Lokacija: Mengeš, Slovenia
Interni naziv pozicije / Internal job title: Višji ekspert upravljanja kakovosti – skladnost / Senior QA Compliance Expert
Relocation Support: This role is based in Mengeš, Slovenia. Novartis is unable to offer relocation support: please only apply if accessible.

Ste pripravljeni na karierno priložnost, kjer bo vaš prispevek ključen pri uvajanju inovativnih zdravil na trg? Na našem oddelku za kakovost – skladnost, male molekule, iščemo strokovnjaka za upravljanje kakovosti, ki bo s svojim znanjem in izkušnjami povezoval in usklajeval regulativne CMC aktivnosti, povezane z lansiranjem zdravil ter aktivnostmi po njihovi odobritvi. Če vas veseli delo, ki neposredno vpliva na pravočasno dostopnost naprednih terapij ter zagotavljanje najvišjih standardov kakovosti, vas vabimo, da se nam pridružite in pustite svoj pečat.

_______________

Are you ready for a career opportunity where your contribution plays a key role in bringing innovative medicines to market? Within our Quality – Compliance, Small Molecules department, we are looking for a Quality Management expert who will leverage their expertise to coordinate and align CMC regulatory activities related to product launches and post-approval processes. If you are motivated by work that enables timely patient access to advanced therapies while upholding the highest quality standards, we invite you to join us and make your mark.

Vaše ključne odgovornosti:

• Delovati kot osrednja kontaktna oseba in strokovni svetovalec za globalno CMC regulativno obveščenost na lokaciji.
• Tesno sodelovati z Global Regulatory CMC ter spremljati in uvajati nove regulativne zahteve, strategije in trende.
• Izvajati neodvisne predhodne ocene zahtevkov za spremembe ter potrjevati ustrezno klasifikacijo kategorije I ali II.
• Zagotavljati pravilnost, popolnost in pravočasnost regulativno relevantnih informacij v zahtevkih za spremembe.
• Podpirati lokacijo pri razvoju učinkovitih strategij nadzora sprememb z večjim vplivom na produkte ali lokacije.
• Omogočati pripravo visokokakovostne CMC dokumentacije in modulov v skladu z dogovorjenimi CMC strategijami.
• Usposabljati in razvijati sodelavce glede regulativnih vidikov upravljanja sprememb ter krepiti kulturo skladnosti.

Vaš doprinos k delovnem mestu:

• Univerzitetna izobrazba farmacevtske, biološke, kemijske, mikrobiološke ali druge ustrezne naravoslovne smeri.
• Aktivno znanje angleškega jezika.

• Minimalno 5 let delovnih izkušenj na področju regulative ali druge strokovne izkušnje na področju kakovosti.

• Dobro poznavanje lokalnih in globalnih regulativnih zahtev ter postopkov za nove kemične enote (NCE) in upravljanje življenjskega cikla izdelkov.
• Odlične komunikacijske in pogajalske sposobnosti ter sposobnost strateškega razmišljanja v kompleksnem okolju.
• Dobro poznavanje orodij Microsoft Office, projektnega dela ter sistemov za upravljanje dokumentacije, z visoko sposobnostjo učenja novih orodij.

Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev Prijavo oddajte z življenjepisom v angleškem jeziku.

Ugodnosti in nagrajevanje: Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, možnost vključitve v kolektivno zdravstveno zavarovanje, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju fizičnega in duševnega dobrega počutja ter delovne obremenitve (Polni življenja), številne priložnosti za učenje in razvoj.

V Novartisu smo predani soustvarjanju medicine in nagrajevanju ljudi, ki to omogočajo.

Pričakovani razpon plače za to delovno mesto:

39.270,00 - 72.930,00 EUR

Osnovna plača se določa na podlagi vnaprej opredeljenih in transparentnih kriterijev, kot so relevantne veščine, kompetence in izkušnje, ne glede na spol, ter v skladu z Novartisovo politiko določanja plač. Po zaposlitvi v Novartisu se plača periodično pregleda v skladu z internimi akti in postopki.

Poleg osnovne plače ste lahko upravičeni tudi do kratkoročnega bonusa, ki je odvisen od določenih meril uspešnosti.

Ugodnosti zaposlitve v Novartisu vključujejo več kot le osnovno plačo in variabilno nagrajevanje. Zaposlenim nudimo nabor konkurenčnih ugodnosti, ki podpirajo strokovni in osebni razvoj, vključno s programi zavarovanj, pokojninsko shemo, aktivnostmi za dobro počutje ter programe za prepoznavanje dosežkov zaposlenih v skladu z internimi akti delodajalca. Kjer narava dela dopušča, omogočamo tudi prilagodljive in hibridne oblike dela ter najmanj 14 tednov plačanega starševskega dopusta.

Pravično plačilo je temeljno načelo naše zaposlitvene politike in odraža našo zavezanost ustvarjanju raznolikega, pravičnega in vključujočega okolja, ki vse zaposlene obravnava z dostojanstvom in spoštovanjem, kot je določeno v našem Etičnem kodeksu.

Za več informacij o nagrajevanju si oglejte našo globalno brošuro: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Opomba: Ugodnosti in nadomestila se lahko razlikujejo glede na državo in so predmet lokalnih zakonskih zahtev, vključno z določbami kolektivnih pogodb, kjer je to ustrezno. Celoten pregled vašega paketa ugodnosti, vključno z vsemi ustreznimi podrobnostmi kolektivnih pogodb, ki veljajo za vašo delovno mesto glede na lokacijo zaposlitve in pravno osebo Novartis, bo posredovano ločeno med postopkom prijave.

___________________________________

Key Responsibilities:

• Act as the primary contact and expert advisor for global CMC regulatory intelligence at the site.
• Collaborate closely with Global Regulatory CMC to monitor and implement new regulatory requirements and strategies.
• Perform independent pre-assessments of change requests and confirm appropriate Category I or II classification.
• Ensure accuracy, completeness, and timeliness of regulatory-relevant information within change documentation.
• Support the site in developing effective change control strategies with broader product or site impact.
• Enable timely preparation of high-quality CMC documentation and modules aligned with agreed CMC strategies.
• Train and develop site colleagues on regulatory change management to strengthen compliance capabilities.

Essential Requirements:

• University degree in pharmacy, biology, chemistry, microbiology, or another relevant life science discipline.
• Proficient command of the English language.

• Minimum 5 years of working experience in regulatory affairs or other quality functions on expert position.

• Solid knowledge of local and global regulatory requirements, including submission processes for new chemical entities (NCE) and product lifecycle management.
• Strong communication and negotiation skills combined with strategic thinking in a cross-functional setting.
• Proficiency in Microsoft Office tools, project-based work, and document management systems, with a strong ability to learn new tools quickly.

We offer permanent employment with 6 months of probation period. Submit your application with the CV in English language.

Benefits and Rewards: Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (Well-being), Unlimited learning and development opportunities.

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role:

39.270,00 - 72.930,00 EUR

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:

https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired

Collaboration, Communication Skills (Inactive), Data Integrity, Decision Making, Digital saviness (Inactive), Leadership, Managing Ambiguity, Organizational Saviness (Inactive), Regulatory Requirements knowledge (Inactive), Risk Management