摘要
Kot Globalni vodja kakovosti za procese kontrole kakovosti ter analitske znanosti in tehnologije boste odgovorni za vodenje strategije in vključevanje vseh strateških in operativnih pobud za zagotavljanje doslednih in usklajenih standardov v vseh laboratorijih, učinkovitosti laboratorijev ("vitki laboratoriji") in skladnih analitičnih sistemov s kompetentnimi in učinkovitimi organizacijami za AS&T in QC na platformah IM SM in LMM. Ta vloga je stalni član skupine za vodenje kakovosti platform IM SM in LMM ter globalne skupine za vodenje kakovosti AS&T / QC.
Imate strast in zanimanje za tehnološke inovacije? Dobrodošle so prijave z mednarodnimi/globalnimi izkušnjami z uporabnim znanjem in izkušnjami na področju analitičnih orodij in strategij testiranja!
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We are seeking a Global Head QC/AS&T NTO Quality. In this role, you will be responsible for driving the strategy and integration of all strategic and operational initiatives to ensure consistent & harmonized standards across all laboratories, laboratory efficiency (“lean labs”) and compliant analytical systems with competent and efficient organizations for AS&T and QC in IM SM & LMM platforms. This role is a permanent member of the IM SM and LMM Platform Quality Leadership Team and the Global AS&T / QC Quality Leadership Team.
Do you have passion and interest for technological innovation? We welcome applications with international/global experience with applied knowledge and experience in analytical tools and testing strategies!
About the Role
Deadline for applications: 21st of March 2025.
Vaše ključne odgovornosti:
- Spodbuja izvajanje strategije kontrole kakovosti za zagotavljanje skladnosti in učinkovitosti laboratorijev kontrole kakovosti v organizaciji IM SM in LMM.
- Spodbuja globalno standardizacijo/integracijo analitičnih poslovnih procesov in informacij, podatkov, globalnih standardov opreme in arhitekture aplikacij.
- Opredeljuje in uveljavlja veljavne standarde, postopke in modul kakovosti ter direktive, globalne SOP za analitske laboratorije, kot to zahtevajo standardi cGMP. Ohranja ozaveščenost o regulativnih zahtevah, ki vplivajo na farmacevtsko industrijo.
- Podpira pripravo kritičnih inšpekcijskih pregledov HA, vključno s podporo med samim pregledom, kadar je to potrebno.
- Vodenje programa ukrepov za QC/AS&T z opredelitvijo in izvajanjem ustreznih načrtov za ekipe QC/AS&T v okviru platforme, zagotavljanjem skladnosti, stalnega izboljševanja in povečanja učinkovitosti vseh vrst testiranja kontrole kakovosti. Sprožiti, izvajati in vzdrževati pobude, ki jih opredeli globalno QC/AS&T.
- Zagotavljanje in spodbujanje sodelovanja med lokacijami ter preglednost skupnih pobud, vprašanj in pridobljenih izkušenj.
- Spodbujanje pobud za posodobitev funkcij preskušanja.
- Ocenjevanje in uvajanje novih tehnologij/sistemov/programske opreme, ki lahko izboljšajo kakovost obstoječih strategij preskušanja control kakovosti in/ali povečajo produktivnost laboratorija.
- Podpirati razvoj tehničnih in vodstvenih spretnosti članov platforme/skupine na lokaciji. Usposabljanje in razvijanje ljudi. Izvajati programe usposabljanja, ki jih je razvila globalna funkcija QC/AS&T, in dejavno sodelovati pri razvoju ustreznega gradiva za usposabljanje.
Vaš doprinos k delovnem mestu:
- Izobrazba s področja znanosti o življenju, vključno z analitično kemijo, biokemijo in mikrobiologijo ali sorodnim področjem, ali enakovredne izkušnje.
- 5 do 10 let pomembnih in obsežnih tehničnih izkušenj na področju analitičnega razvoja in/ali nadzora kakovosti na lokaciji in svetovni ravni. Dokazano znanje in izkušnje z zahtevami cGMP.
- Dokazane vodstvene, medosebne, komunikacijske in pogajalske sposobnosti, sposobnosti reševanja problemov ter uveljavljene izkušnje pri razvoju osebja.
- Spretnosti za upravljanje projektov in sprememb.
- Tekoče pisno in govorno znanje angleščine.
Zaželene izkušnje:
- Poznavanje procesov avtomatizacije v analitičnih laboratorijih.
- Izkušnje s pristopi za izboljšanje procesov in podatkovno znanostjo.
Z izbranim kandidatom bomo sklenili delovno razmerje za ne/določen čas s poskusno dobo 6 mesecev. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.
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.
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Key Responsibilities :
- Drives QC strategy implementation to leverage compliance and efficiency for QC Labs across the IM SM & LMM organization.
- Drives global standardization/integration of analytical business processes and information, data, global equipment standards and application architecture.
- Defines and enforces current standards, procedures and Quality module and directives, Global SOPs for Analytical Laboratories as required by cGMPs. Maintains awareness of regulatory requirements affecting the pharmaceutical industry.
- Supports preparation of critical HA inspections incl. support during the inspection itself where necessary.
- Drive the QC/AS&T action agenda by defining and implementing appropriate plans for the QC/AS&T teams across the platform, ensuring compliance, continual improvement and efficiency increase of any type of QC testing. Initiate, implement and sustain initiatives defined by Global QC/AS&T.
- Ensure and drive cross-site collaboration and transparency on common initiatives, issues and lessons learned.
- Pursue modernization initiatives in testing functions.
- Evaluate and implement new technologies/systems/software that have the potential to improve the quality of existing QC testing strategies and/or enhance laboratory productivity.
- Support the development of platform / site team members in technical and leadership skills. Coach and develop people. Implement training programs developed by the global QC/AS&T function and actively participate in development of appropriate training materials.
Essential Requirements:
- Education: Advanced degree in Life sciences including Analytical Chemistry, Biochemistry and Microbiology or related area or equivalent experience.
- 5-10 years of significant, broad technical experience in Analytical Development and/or Quality Control functions at site and global level. Demonstrated knowledge and experience with cGMP requirements.
- Demonstrated leadership, interpersonal, communication, negotiation, problem solving skills and established record of staff development.
- Project and change management skills.
- Fluent English, written and spoken.
Desirable Requirements :
- Understanding of Automation processes in Analytical labs would be highly valued.
- Experience in process improvement approaches and data science.
We offer permanent/temporary employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.
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 (Wellbeing), 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.
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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
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.
