REQ-10001098
Maj 16, 2024
Slovenia

Sammanfattning

Location: Ljubljana #LI-Hybrid As QA Senior Manager you will be responsible for the development and verification of the internal quality system compliance to mitigate risks related to product/API quality and to reduce costs associated to poor product quality, pursuant to the law, internal regulations, good practices and business objectives. Responsibility for the development and transfer of expert quality-related skills. 

About the Role

Your key responsibilities
• QA Champion for global and cross-functional projects related to distribution and warehousing and project manager for assigned projects.
• QA responsibility for the selection, qualification and implementation of global reliable transport providers, global forwarders, control towers, logistics hubs, distribution centers for all transport modes and distribution lanes according to the GDP guidelines and Novartis quality modules.
• Prepare QA agreement templates and negotiate QA agreements for warehousing, distribution and international transport with internal and external partners. Ensure that the established QA agreements are kept up to date.
• Ensure robust QA oversight on the compliance operations and management of the globally managed transport providers and logistics hubs.
• Owner and moderator of regular Transport Committee Meetings ensuring alignment between QA and Operations.
• Ensure compliance with GDP and regulatory requirements (including record management) and continuous improvement of quality relevant processes within the area of responsibility.
• Define and apply harmonized high quality standards in the selection and management of transport and logistics providers, shipment container- and lane qualification, transport validation and temperature monitoring.
• QA support for manufacturing plants, CPOs and affiliates in transport and logistics providers’ management.

What you will bring to the role
• Degree in life sciences, preferably in pharmacy or chemistry or equivalent.
• Fluent in spoken and written English.
• Pharmaceutical Quality Assurance with compliance experience.
• Strong experience in GDP.
• Leadership and Supply Chain experience.

We offer permanent employment, with 6 months of probation period.

You are kindly invited to submit your application in English language, including CV.

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities.

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.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

_______________________________________

For Slovenia:

Lokacija: Ljubljana #LI-Hybrid

Kot Ekspert upravljanja kakovosti I boste odgovorni za razvoj in preverjanje skladnosti internega sistema kakovosti s ciljem zniževanja rizikov povezanih s kakovostjo izdelkov/učinkovin in zniževanja stroškov slabe kakovosti, skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji. Odgovornost za razvoj in prenos ekspertnih znanj s področja kakovosti. 


Vaše ključne odgovornosti
• Opravljanje vloge predstavnika za upravljanje kakovosti (QA) za globalne in medfunkcijske projekte, ki so povezani z distribucijo in skladiščenjem ter opravljanje vloge vodje projekta za dodeljene projekte.
• Prevzemanje odgovornost za upravljanje kakovosti (QA) pri izbiri, kvalifikaciji in implementaciji zanesljivih globalnih ponudnikov transportnih storitev, globalnih špediterjev, nadzornih stolpov, logističnih in distribucijskih centrov za vse vrste transporta in distribucijske poti v skladu s smernicami dobre distribucijske prakse (GDP) in Novartisovimi moduli kakovosti.
• Priprava in pogajanje o predlogih sporazumov oz. pogodb o upravljanju kakovosti (QA) za skladiščenje, distribucijo in mednarodni transport z notranjimi in zunanjimi partnerji. Posodabljanje sporazumov o upravljanju kakovosti (QA).
• Zagotavljanje zanesljivega nadzora nad upravljanjem kakovosti glede dejavnosti na področju skladnosti in upravljanja ponudnikov transportnih storitev in logističnih centrov na globalni ravni.
• Vodenje in koordiniranje rednih sestankov odbora za transport, s čimer se zagotavlja usklajenost med upravljanjem kakovosti in poslovanjem.
• Zagotavljanje skladnosti z dobro proizvodno prakso (GDP) in regulatornimi zahtevami (vključno z upravljanjem evidenc) ter nenehno izboljševanje procesov kakovosti.
• Opredelitev in uporaba usklajenih visokokakovostnih standardov pri izbiri in upravljanju ponudnikov prevoznih in logističnih storitev, kvalifikaciji kontejnerjev in kanalov za odpremljene pošiljke, validaciji transporta in nadzorovanju temperature.
• Nudenje podpore pri upravljanju kakovosti za proizvodne obrate, CPO-je in podružnice za prevozne in logistične storitve

Vaš doprinos k delovnem mestu
• Visokošolska stopnja izobrazba iz farmacije, kemije ali druge ustrezne smeri.
• Aktivno znanje angleškega jezika.
• Izkušnje iz upravljnja kakovosti in skladnosti iz farmacevtske industrije.
• Izkušnje z dobro distribucijsko prakso (GDP).
• Izkušnje z vodenjem in oskrbovalno verigo.

Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.

Prijave z življenjepisom v angleškem in slovenskem jeziku pošljite preko spletne strani.

Zakaj Novartis?
Naš namen je soustvarjati medicino za izboljšanje in podaljševanje življenja ljudi, naša vizija pa je postati najbolj cenjeno in zaupanja vredno farmacevtsko podjetje na svetu. Kako lahko to dosežemo? S pomočjo naših ljudi. Prav naši sodelavci nas vsak dan spodbujajo, da dosežemo svoje ambicije. Postanite del te misije in se nam pridružite! Več na spodnji povezavi: https://www.novartis.com/about/strategy/people-and-culture

Kaj nudimo:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj.

Predani smo raznolikosti in vključenosti
Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.

Pridružite se naši mreži Novartis: V kolikor se ne prepoznate v zgornjem opisu delovnega mesta, vas vabimo, da se vpišete na spodnji povezavi v Novartisovo bazo talentov saj lahko tako vašo vlogo upoštevamo za podobne pozicije v prihodnosti: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Operations
Pharmaceuticals
Slovenia
Ljubljana
Quality
Full time
Regular
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

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REQ-10001098

Ekspert upravljanja kakovosti I/ QA Senior Manager (m/f/d)

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