Vodja kakovosti (m/ž/d) / Site Quality Head (m/f/d)

<p style="text-align:left"><b>Job Description Summary</b></p>#LI-Hybrid <br>Lokacija / Location: Ljubljana, Slovenia<br><br>Vas zanima vodilna vloga na področju kakovosti v okolju vrhunskih farmacevtskih inovacij?<br>Iščemo Vodjo kakovosti, ki bo navdihoval in opolnomočil ekipo, da doseže nove ravni uspeha. V tej ključni vlogi boste razvijali talente in spodbujali pozitivno delovno okolje, s čimer boste razvili celotni potencial svoje ekipe, hkrati pa uvajali robustne procese zagotavljanja kakovosti in kontrolne sisteme, ki zagotavljajo, da vsak izdan izdelek izpolnjuje najvišje standarde zanesljivosti. V tesnem sodelovanju z globalno ekipo za kakovost platforme in z neposrednim poročanjem Vodji globalne kakovosti platforme boste zagotavljali uspeh z doslednim spoštovanjem zakonodaje, internih predpisov in najboljših praks v panogi. Krepili boste zaupanje strank in deležnikov ter zagotavljali, da naša organizacija uspeva v konkurenčnem okolju.<br><br>-------------------------------------<br><br>Ready to lead quality excellence at the forefront of pharmaceutical innovation? <br><br>We are seeking a Site Quality Head who will inspire and empower the team to reach new heights of success. In this pivotal role, you’ll nurture talent and foster a positive work environment, unlocking your team’s full potential while implementing robust quality assurance processes and control systems that guarantee every release meets the highest standards of reliability. Working directly with the Global Quality Platform team and reporting to the Global Quality Platform Head, you will drive success by upholding legislation, internal regulations, and industry best practices, instilling trust in customers and stakeholders, and ensuring our organization thrives in a competitive landscape.<p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Job Description</b></p><p><b>Vaše</b><b> </b><b>ključne</b><b> </b><b>odgovornosti</b><b>:</b></p><ul><li>Vodenje organizacije kakovosti lokacije in zagotavljanje robustnega nadzora nad vsemi GxP funkcijami.</li><li>Delovanje kot strokovno odgovorna oseba (QP), kadar to zahtevajo regulativni standardi.</li><li>Razvoj in implementacija ocen tveganja kakovosti na lokaciji ter strategij skladnosti.</li><li>Zagotavljanje upoštevanja zahtev cGxP, integritete podatkov in e-skladnosti (eCompliance) v vseh operacijah.</li><li>Spodbujanje razvoja talentov preko zaposlovanja, usposabljanja, coachinga in upravljanja uspešnosti.</li><li>Spodbujanje raznolikosti ter vzpostavitev kariernih poti in načrtov nasledstev na ravni lokacije in enot.</li><li>Zagotavljanje, da so sodelavci ustrezno GMP-usposobljeni, preden samostojno izvajajo naloge.</li><li>Ohranitev stalne pripravljenosti na inšpekcije in vodenje kakovostnih vidikov pri obvladovanju kriznih situacij.</li><li>Prevzemanje delegiranih odgovornosti odločanja v okviru sistema dežurnega vodenja (on-call management).</li></ul><p></p><p><b>Vaš</b><b> </b><b>doprinos</b><b> k </b><b>delovnem</b><b> </b><b>mestu</b><b>: </b></p><ul><li>10&#43; let izkušenj na področju kakovosti, razvoja ali proizvodnje v sterilni farmacevtski proizvodnji.</li><li>Univerzitetna izobrazba iz farmacije, kemije, mikrobiologije ali druge naravoslovne smeri.</li><li>Funkcionalno znanje angleškega in slovenskega jezika kot delovnih jezikov.</li><li>Zmožnost učinkovitega delovanja v nejasnih in kompleksnih okoljih.</li><li>Močne veščine medfunkcijskega sodelovanja z globalnimi ekipami.</li><li>Znanje in izkušnje na področju aseptične proizvodnje.</li><li>Dokazane izkušnje z inšpekcijami regulatornih organov (zlasti ameriške FDA) ter po možnosti z inšpekcijami predhodne odobritve (pre-approval inspection, PAI) proizvodnega obrata.</li><li>Tekoče znanje angleščine v pisni in govorni obliki.</li></ul><p></p><p><span><span>Z </span><span>izbranim</span><span> </span><span>kandidatom</span><span> </span><span>bomo</span><span> </span><span>sklenili</span><span> </span><span>delovno</span><span> </span><span>razmerje</span><span> za </span></span><b><span>nedoločen</span><span> </span><span>čas</span></b><span><span> s </span><span>poskusno</span><span> </span><span>dobo</span><span> </span></span><b><span>6 </span><span>mesecev</span></b><span><span>. </span></span><span><span>Prijavo</span><span> </span><span>oddajte</span><span> z </span><span>življenjepisom</span><span> v </span><span>slovenskem</span><span> in </span><span>angleškem</span><span> </span><span>jeziku</span><span>.</span></span><span> </span></p><p></p><p><b><span>Ugodnosti in nagrajevanje: </span></b><span> </span></p><p><span><span>Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, </span></span><span><span>možnost vključitve v kolektivno zdravstveno zavarovanje,  </span></span><span><span>shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju </span></span><span><span>fizičnega</span><span> in </span><span>duševnega</span><span> </span><span>dobrega</span><span> </span><span>počutja</span><span> ter </span><span>delovne</span><span> </span><span>obremenitve</span><span> (</span><span>Polni</span><span> </span><span>življenja</span><span>).</span></span><span><span>), številne priložnosti za učenje in razvoj.  </span></span></p><p></p><div><p><span><span>Preberite</span><span> </span><span>naš</span><span> </span><span>priročnik</span><span>, da </span><span>spoznate</span><span> </span><span>načine</span><span>, s </span><span>katerimi</span><span> </span><span>bomo</span><span> </span><span>spodbujali</span><span> </span><span>vaš</span><span> </span><span>osebni</span><span> in </span><span>profesionalni</span><span> </span><span>razvoj</span><span>: </span></span><a href="https://www.novartis.com/careers/benefits-rewards" target="_blank"><u><span>https://www.novartis.com/careers/benefits-rewards</span></u></a><span><span> </span><span>   </span></span><span> </span></p></div><div><p><span><span>  </span></span><span> </span></p></div><div><p><b><span>Predani</span><span> </span><span>smo</span><span> </span><span>raznolikosti</span><span> in </span><span>vključenosti</span><span>: </span></b><span><span>Novartis si </span><span>prizadeva</span><span> </span><span>ustvariti</span><span> </span><span>izjemno</span><span>, </span><span>vključujoče</span><span> </span><span>delovno</span><span> </span><span>okolje</span><span> in </span><span>oblikovanje</span><span> </span><span>raznolikih</span><span> </span><span>timov</span><span>, </span><span>saj</span><span> </span><span>ti</span><span> </span><span>predstavljajo</span><span> </span><span>naše</span><span> </span><span>bolnike</span><span> in </span><span>skupnosti</span><span>, ki </span><span>jih</span><span> </span><span>oskrbujemo</span><span>.  </span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><b><span>Zakaj</span><span> Novartis:</span></b><span><span> </span><span>Pomagati</span><span> </span><span>bolnikom</span><span> in </span><span>njihovim</span><span> </span><span>družinam</span><span> </span><span>zahteva</span><span> </span><span>več</span><span> </span><span>kot</span><span> le </span><span>inovativno</span><span> </span><span>znanost</span><span>. </span><span>Potrebna</span><span> je </span><span>skupnost</span><span> </span><span>zavzetih</span><span> </span><span>ljudi</span><span>, </span><span>kot</span><span> </span><span>ste</span><span> vi. V </span><span>Novartisu</span><span> </span><span>cenimo</span><span> </span><span>sodelovanje</span><span>, </span><span>podporo</span><span> in </span><span>navdihovanje</span><span> drug </span><span>drugega</span><span> za </span><span>razvoj</span><span> </span><span>prebojnih</span><span> </span><span>terapij</span><span>, ki </span><span>spreminjajo</span><span> </span><span>življenja</span><span> </span><span>pacientov</span><span>. Ste </span><span>pripravljeni</span><span> </span><span>ustvariti</span><span> </span><span>svetlejšo</span><span> </span><span>prihodnost</span><span> </span><span>skupaj</span><span> z </span><span>nami</span><span>? </span></span><a href="https://www.novartis.com/about/strategy/people-and-culture" target="_blank"><u><span>https://www.novartis.com/about/strategy/people-and-culture</span></u></a><span><span>    </span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><b><span>Pridružite</span><span> se </span><span>Novartisu</span></b><span><span>: Ni </span><span>pravo</span><span> </span><span>delovno</span><span> mesto za vas? </span><span>Prijavite</span><span> se v </span><span>našo</span><span> </span><span>bazo</span><span> </span><span>talentov</span><span>, da </span><span>ostanete</span><span> v </span><span>kontaktu</span><span> z </span><span>nami</span><span> in se </span><span>seznanite</span><span> z </span><span>ustreznimi</span><span> </span><span>kariernimi</span><span> </span><span>priložnostmi</span><span> </span><span>takoj</span><span>, ko se </span><span>pojavijo</span><span>: </span></span><a href="https://talentnetwork.novartis.com/network" target="_blank"><u><span>https://talentnetwork.novartis.com/network</span></u></a><span><span>   </span></span><span><span> </span></span><span> </span></p></div><p></p><p><span><span>________________________</span></span><span> </span></p><p></p><div><p><b><span>Key Responsibilities:</span></b></p></div><ul><li><span>Lead the Site Quality organization and ensure robust oversight of all GxP functions.</span></li><li><span>Act as Technical Responsible Person (Qualified Person) when required by regulatory standards.</span></li><li><span>Develop and implement site quality risk assessments and compliance strategies.</span></li><li><span>Ensure adherence to cGxP, data integrity, and eCompliance requirements across operations.</span></li><li><span>Drive talent agenda through recruitment, training, coaching, and performance management.</span></li><li><span>Foster diversity and deploy career paths and succession plans for site and unit.</span></li><li><span>Guarantee associates are GMP-qualified before performing independent tasks.</span></li><li><span>Maintain inspection readiness and lead quality aspects of crisis management.</span></li><li><span>Assume delegated decision-making responsibilities under on-call management framework.</span></li></ul><div><p></p><p><b><span>Essential Requirements:</span></b></p></div><ul><li><span>10&#43; years of experience in quality, development, or production within<span> </span></span><span>sterile<span> </span></span><span>pharmaceutical</span><span> <span> </span><span>manufacturing</span><span>.</span></span></li><li><span>University degree in Pharmacy, Chemistry,</span><span><span> </span><span>Microbiology</span><span><span> </span>or another natural science discipline.</span></span></li><li><span>Functional proficiency in English and Slovenian as working languages.</span></li><li><span>Ability to operate effectively in ambiguous and complex environments.</span></li><li><span>Strong cross-functional collaboration skills with global teams.</span></li><li><span>Knowledge and experience in aseptic processing.</span></li><li><span>Proven track record in Health Authority inspections</span><span>,<span> </span><span>specifically US FDA; Facility pre-approval experience preferred</span><span>.</span></span></li><li><span>Fluent English, written and spoken.</span></li></ul><p></p><p><span><span>We offer </span></span><b><span>permanent employment </span></b><span><span>with </span></span><b><span>6 </span><span>months</span></b><span><span> of</span><span> probation period. </span><span>Submit your application with the CV in Slovenian and English language.</span></span><span> </span></p><p></p><p><b><span>Benefits and Rewards:</span></b><b><span> </span></b><span><span> </span></span><span> </span></p><p><span><span>Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, </span><span>possibility of joining collective health insurance</span><span> scheme</span><span>,</span><span> </span><span>Employee Recognition Scheme, Expanded program for the promotion of health in the field of </span></span><span><span>physical and mental well-being and managing workload </span></span><span><span>(We</span><span>ll-being</span></span><span><span>), Unlimited learning and development opportunities</span><span>.  </span></span></p><p></p><p><b><span>Commitment to Diversity and Inclusion:</span></b><span><span> </span><span>Novartis is committed to building an outstanding, inclusive work environment and diverse teams&#39; </span><span>representative</span><span> of the patients and communities we serve.</span></span><span> </span></p><p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Skills Desired</b></p>