Director, Global TRD QA Sterility Assurance

Job description

Salary Range: €75,880.00 - €140,920.00 Job Description Summary Location: Menges, Slovenia #onsite Role Purpose: Establish, lead, and continuously develop the TRD QA Sterile Operations Network, fostering accountability, learning, and collaboration. Provide specialist knowledge and guidance on sterile and low bioburden processes, ensuring compliance with regulatory requirements. Implement, harmonize, and continuously improve aseptic standards and best practices across TRD pilot plants and all modalities (Cell and Gene Therapies, Radioligand Therapies, ADC, and New Biological Entities). Act as a key partner in cross-functional projects, troubleshooting issues and aligning stakeholders on pragmatic solutions and standards. Mentor and develop members of the TRD QA Sterile Operations Network, addressing critical skills gaps. Consult on the evaluation and selection of external contractors for aseptic appropriateness, ensuring integrity of outsourced processes. Lokacija: Menges, Slovenija #onsite Namen vloge: Vzpostaviti, voditi in nenehno razvijati TRD QA Sterile Operations Network ter spodbujati odgovornost, učenje in sodelovanje. Nudite strokovno znanje in usmeritve o sterilnih in nizkobiološko zahtevnih procesih, da zagotovite skladnost z regulativnimi zahtevami. Uvajati, usklajevati in nenehno izboljševati standarde in najboljše prakse aseptičnih elektrarn ter vseh modalitet TRD (celične in genske terapije, radioligandske terapije, ADC in nove biološke entitete). Biti ključni partner pri medfunkcijskih projektih, odpravljati težave in usklajevati deležnike glede pragmatičnih rešitev in standardov. Mentorirati in razvijati člane TRD QA Sterile Operations Network ter naslavljati kritične vrzeli v znanju. Posvetujte se pri ocenjevanju in izbiri zunanjih izvajalcev glede aseptične ustreznosti, s čimer zagotovite integriteto zunanjih procesov. Job Description Major Accountabilities: Establish, lead, and continuously develop a TRD QA Sterile Operations Network, fostering accountability, learning, and collaboration. Provide specialist knowledge and guidance on sterile and low bioburden processes, ensuring compliance with regulatory requirements. Implement, harmonize, and continuously improve aseptic standards and best practices across TRD pilot plants and across all modalities (Cell and Gene Therapies, Radioligand Therapies, ADC, and New Biological Entities). Drive continuous improvement, knowledge transfer, and innovation in sterility assurance. Act as a key partner in cross-functional projects, troubleshooting issues and aligning stakeholders on pragmatic solutions and standards. Mentor and develop members of the TRD QA Sterile Operations Network, addressing critical skills gaps. Consult on the evaluation and selection of external contractors for aseptic appropriateness, ensuring integrity of outsourced processes. Desired skills: Influence without authority in a matrix environment—build credibility, align stakeholders, and drive standards adoption. Proactive relationship-building—actively engage cross-functional partners to create momentum for change. Pragmatic risk-taking—balance diligence with smart, solution-oriented decision-making. Advanced problem-solving—lead troubleshooting and resolution across departmental boundaries. Effective communication—tailor messaging, negotiate, and handle pushback diplomatically. Political savvy—navigate informal networks and overcome barriers to secure a seat at the table. Qualifications Advanced degree (PhD, MSc, or equivalent) in life sciences, pharmacy, or related field Extensive experience in sterile manufacturing, quality assurance, or related areas within the pharmaceutical/biotech industry Strong knowledge of aseptic processing, sterility assurance, and regulatory requirements (e.g., FDA, EMA, ICH) Proven track record in leading cross-functional teams or networks, ideally in a matrix environment Demonstrated ability to influence without authority and drive change across organizational boundaries Excellent problem-solving, communication, and stakeholder management skills Fluent in English; additional languages a plus Benefits & Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: €75,880 to €140,920 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. Glavne odgovornosti: Vzpostaviti, voditi in nenehno razvijati TRD QA Sterile Operations Network, kar spodbuja odgovornost, učenje in sodelovanje. Nudite strokovno znanje in usmeritve o sterilnih in nizkobiološko zahtevnih procesih, da zagotovite skladnost z regulativnimi zahtevami. Uvajanje, usklajevanje in stalno izboljševanje standardov in najboljših praks aseptičnih zdravil v pilotnih obratih TRD in vseh modalitetah (celične in genske terapije, radioligandske terapije, ADC in nove biološke entitete). Spodbujajte neprekinjeno izboljševanje, prenos znanja in inovacije na področju zagotavljanja sterilnosti. Biti ključni partner pri medfunkcijskih projektih, odpravljati težave in usklajevati deležnike glede pragmatičnih rešitev in standardov. Mentorirati in razvijati člane TRD QA Sterile Operations Network ter naslavljati kritične vrzeli v znanju. Posvetujte se pri ocenjevanju in izbiri zunanjih izvajalcev glede aseptične ustreznosti, s čimer zagotovite integriteto zunanjih procesov. Želene veščine: Vplivajte brez avtoritete v matriksnem okolju – gradite kredibilnost, uskladite deležnike in spodbujajte sprejemanje standardov. Proaktivno gradnjo odnosov – aktivno vključevanje medfunkcijskih partnerjev za ustvarjanje zagona za spremembe. Pragmatično sprejemanje tveganja – uravnotežite prizadevnost s pametnim, rešilno usmerjenim odločanjem. Napredno reševanje problemov – vodenje odpravljanja težav in reševanje čez meje oddelkov. Učinkovita komunikacija – prilagodite sporočila, pogajajte se in diplomatsko reševajte odpor. Politična spretnost – krmarite po neformalnih mrežah in premagujte ovire, da si zagotovite sedež za mizo. Kvalifikacije Napredna stopnja (PhD, MSc ali ekvivalent) iz življenjskih ved, farmacije ali sorodnega področja Obsežne izkušnje na področju sterilne proizvodnje, zagotavljanja kakovosti ali sorodnih področij v farmacevtski/biotehnološki industriji Močno znanje o aseptični obdelavi, zagotavljanju sterilnosti in regulativnih zahtevah (npr. FDA, EMA, ICH) Dokazana uspešnost pri vodenju medfunkcijskih ekip ali omrežij, idealno v matrikskem okolju Dokazana sposobnost vplivanja brez avtoritete in spodbujanja sprememb preko organizacijskih meja Odlične veščine reševanja problemov, komunikacije in upravljanja deležnikov tekoče govori angleško; dodatni jeziki so plus Koristi in nagrade V Novartisu smo zavezani skupnemu preoblikovanju medicine – in nagrajevanju ljudi, ki jo uresničijo. Pričakovana letna osnovna plača Razpon za delovno mesto: €75.880 do €140.920 Osnovna plača je določena glede na spolno nevtralne cilje, kot so relevantne veščine, kompetence in izkušnje v skladu s politiko plač Novartisa, ob vstopu v Novartis pa se redno pregleduje. Poleg osnovne plače ste morda upravičeni do bonusa na podlagi uspešnosti, odvisno od določenih parametrov uspešnosti. Nagrade, ki jih prinaša članstvo v naši ekipi, segajo daleč preko osnovne plače in spodbud. Ponujamo tudi različne konkurenčne ugodnosti v naravi, ki vam pomagajo uspevati osebno in poklicno, kot so zavarovalni načrti, pokojninski načrti, viri za dobro počutje in globalni programi priznanja. Poleg tega ponujamo prilagodljive in hibridne možnosti dela, kjer je mogoče, ter najmanj 14 tednov plačanega starševskega dopusta. Skills Desired