Globalni vodja uvajanja NETLab / Global NETLab Deployment Lead

Job Description Summary

Odgovornost za vodenje uvajanja NETLab, vključevanje novih lokacij ter upravljanje NETLab skupnosti znotraj ustreznih laboratorijev na lokacijah NTO. Pri tem zagotavlja, da so vse zahteve glede skladnosti izpolnjene in vzdrževane skozi celoten življenjski cikel aplikacije. V tej vlogi mora Globalni vodja uvajanja NETLab prevzeti odgovornosti drugih članov tima NETLab, kadar je to potrebno.
Delovanje skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji.
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The “Global NETLab Deployment Lead” is accountable for leading the deployment of NETLab kits, the onboarding of new sites and the governance of NETLab community within the applicable laboratories in NTO sites, respectively ensuring all compliance requirements are met and maintained through the life cycle of the application.
Za to vlogo ne ponujamo paketa za preselitev. We do not offer relocation package for this role.

 

Job Description

Glavne odgovornosti:

• Vodi in definira načrt ter strategijo uvajanja z namenom čim večje izrabe NETLab kataloga v skupnosti.
• Ponuja podporo lokacijam med uvajanjem NETLab kompletov ter zagotavlja ustrezno komunikacijo.
• Vodi implementacijo NETLab na novih lokacijah/organizacijah, ki so vključene v obseg NETLab. To vključuje usklajevanje aktivnosti od priprave do faze implementacije, vključno z izvedbo potrebnih usposabljanj.
• Spremlja napredek strategije porabe kompletov (Kit Consumption Strategy) z ustreznimi metrikami in ključnimi kazalniki uspešnosti (KPI).
• Zagotavlja stalno podporo skozi celoten življenjski cikel vseh aplikacij, ki jih podpira NETLab, kot poslovni lastnik teh aplikacij.
• Ponuja podporo pri preiskavah tehničnih težav, povezanih z obstoječimi ali novimi kompleti, tako na področju strojne opreme kot poslovnih procesov.
• Deluje kot poslovni sistemski lastnik NETLab (Business System Owner) in odobrava preglede uporabniških dostopov ter periodične preglede aplikacij.
• Ima poglobljeno tehnično znanje o QC/analitičnih delovnih procesih in instrumentih.
• Piše, prispeva k in/ali pregleduje predloge, obrazce, SOP-je (standardne operativne postopke), kadar je to potrebno.
• Spodbuja pobude za izboljšanje standardizacije, usklajevanja in integracije poslovnih procesov, ki jih podpirajo NETLab aplikacije.
• Stremi k stalnim izboljšavam v skladu z obstoječimi in prihodnjimi regulativnimi zahtevami in pričakovanji.
• Skrbi za NETLab portal, da je ustrezno posodobljen in vzdrževan.
• Sodeluje pri pripravi in spremljanju proračuna za NETLab Center odličnosti (CoE), pri čemer zagotavlja, da so zahteve natančno opredeljene in potrjene s strani vseh deležnikov v skladu s cilji.
• Odgovornost za osebni in strokovni razvoj.
• Izvajanje in upoštevanje vseh navodil in zahtev za zagotavljanje varnega dela, varovanja okolja in premoženja.
• Ostale naloge določene z letnim pogovorom o ciljih in s kazalniki uspešnosti.
• Druge naloge po navodilu nadrejenega in naloge na podlagi posebnega imenovanja.

Obligatory requirements:

• Univerzitetna stopnja izobrazbe s področja farmacije, inžiniringa, kemije ali drugega relevantnega področja.
• Minimalno 6 let izkušenj iz farmacevtske industrije. Izkušnje z zagotavljanjem kakovosti ali nadzorom kakovosti, idealno najmanj 3 leta na področju nadzora kakovosti.
• Temeljito poznavanje zahtev cGMP.
• Močno razumevanje regulativnih zahtev za komercialne izdelke.
• Tehnično razumevanje laboratorijskih poslovnih procesov, zlasti laboratorijske opreme in sistemov.
• Idealno razumevanje razvoja in uvajanja IT sistemov.
• Sposoben za timsko delo in doseganje soglasja z dokončno in avtoritativno sposobnostjo odločanja.
• Tekoče znanje angleščine

Major accountabilities:

• Lead and define the deployment plan & strategy to maximize the utilization of the NETLab catalog in the community.
• Assist the sites during the NETLab kit deployment and ensure appropriate communication.
• Lead NETLab implementation at new sites/organizations added to the NETLab scope. This includes coordinating the on-boarding activities since preparation to implementation phases including necessary training.
• Monitoring the progress of the Kit Consumption Strategy with adequate metrics and KPIs.
• Provide ongoing life-cycle support for all NETLab endorsed applications, as business owner of the applications.
• Provide support for investigations on technical issues with existing / new kits related to hardware and business.
• Act as NETLab Business System Owner to provide the approval for the application user access review and periodic review.
• Provide detailed technical knowledge of QC/analytical work processes and instrumentation.
• Write, contribute to, and/or review templates, forms, SOPs as required.
• Facilitate cross-platform initiatives to enhance the standardization, harmonization and integration of the business processes supported by the NETLab applications.
• Seeking continuous improvement according to the current and future regulatory requirements and expectations.
• Own the NETLab portal to ensure it is properly updated and maintained.
• Facilitate budget preparation and tracking for NETLab CoE, ensuring requirements are accurately identified and endorsed by all stakeholders according the target.

Minimum Requirements:

• University degree in Pharmacy, Engineering, Chemistry or equivalent Discipline
• 6 or more years’ experience in the pharmaceutical industry. Experience in QA Operations or QC, ideally minimum 3 years in QC.
• Thorough knowledge of cGMP requirements
• Strong understanding of regulatory requirements for commercial products.
• Technical understanding of laboratory business processes, especially laboratory equipment and systems
• Ideally understanding in IT systems development and deployment
• Team and consensus builder, with definitive and authoritative decision-making ability.
• Fluent English, written and spoken.

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: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards 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.

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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