Director, Global TRD QA Sterility Assurance

Job ID

REQ-10083507

Jul 24, 2026

Slovenia

Available in: English

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, uenje in sodelovanje.Nudite strokovno znanje in usmeritve o sterilnih in nizkobioloko zahtevnih procesih, da zagotovite skladnost z regulativnimi zahtevami.Uvajati, usklajevati in nenehno izboljevati standarde in najbolje prakse aseptinih elektrarn ter vseh modalitet TRD (celine in genske terapije, radioligandske terapije, ADC in nove bioloke entitete).Biti kljuni partner pri medfunkcijskih projektih, odpravljati teave in usklajevati delenike glede pragmatinih reitev in standardov.Mentorirati in razvijati lane TRD QA Sterile Operations Network ter naslavljati kritine vrzeli v znanju.Posvetujte se pri ocenjevanju in izbiri zunanjih izvajalcev glede aseptine ustreznosti, s imer zagotovite integriteto zunanjih procesov.

About the Role

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.QualificationsAdvanced degree (PhD, MSc, or equivalent) in life sciences, pharmacy, or related fieldExtensive experience in sterile manufacturing, quality assurance, or related areas within the pharmaceutical/biotech industryStrong 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 environmentDemonstrated ability to influence without authority and drive change across organizational boundariesExcellent problem-solving, communication, and stakeholder management skillsFluent in English; additional languages a plusBenefits & RewardsAt 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 €140,920The 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, uenje in sodelovanje.Nudite strokovno znanje in usmeritve o sterilnih in nizkobioloko zahtevnih procesih, da zagotovite skladnost z regulativnimi zahtevami.Uvajanje, usklajevanje in stalno izboljevanje standardov in najboljih praks aseptinih zdravil v pilotnih obratih TRD in vseh modalitetah (celine in genske terapije, radioligandske terapije, ADC in nove bioloke entitete).Spodbujajte neprekinjeno izboljevanje, prenos znanja in inovacije na podroju zagotavljanja sterilnosti.Biti kljuni partner pri medfunkcijskih projektih, odpravljati teave in usklajevati delenike glede pragmatinih reitev in standardov.Mentorirati in razvijati lane TRD QA Sterile Operations Network ter naslavljati kritine vrzeli v znanju.Posvetujte se pri ocenjevanju in izbiri zunanjih izvajalcev glede aseptine ustreznosti, s imer zagotovite integriteto zunanjih procesov.elene veine:Vplivajte brez avtoritete v matriksnem okolju - gradite kredibilnost, uskladite delenike in spodbujajte sprejemanje standardov.Proaktivno gradnjo odnosov - aktivno vkljuevanje medfunkcijskih partnerjev za ustvarjanje zagona za spremembe.Pragmatino sprejemanje tveganja - uravnoteite prizadevnost s pametnim, reilno usmerjenim odloanjem.Napredno reevanje problemov - vodenje odpravljanja teav in reevanje ez meje oddelkov.Uinkovita komunikacija - prilagodite sporoila, pogajajte se in diplomatsko reevajte odpor.Politina spretnost - krmarite po neformalnih mreah in premagujte ovire, da si zagotovite sede za mizo.KvalifikacijeNapredna stopnja (PhD, MSc ali ekvivalent) iz ivljenjskih ved, farmacije ali sorodnega podrojaObsene izkunje na podroju sterilne proizvodnje, zagotavljanja kakovosti ali sorodnih podroij v farmacevtski/biotehnoloki industrijiMono znanje o aseptini obdelavi, zagotavljanju sterilnosti in regulativnih zahtevah (npr. FDA, EMA, ICH)Dokazana uspenost pri vodenju medfunkcijskih ekip ali omreij, idealno v matrikskem okoljuDokazana sposobnost vplivanja brez avtoritete in spodbujanja sprememb preko organizacijskih mejaOdline veine reevanja problemov, komunikacije in upravljanja delenikovtekoe govori angleko; dodatni jeziki so plusKoristi in nagradeV Novartisu smo zavezani skupnemu preoblikovanju medicine - in nagrajevanju ljudi, ki jo uresniijo.Priakovana letna osnovna plaa Razpon za delovno mesto: €75.880 do €140.920Osnovna plaa je doloena glede na spolno nevtralne cilje, kot so relevantne veine, kompetence in izkunje v skladu s politiko pla Novartisa, ob vstopu v Novartis pa se redno pregleduje.Poleg osnovne plae ste morda upravieni do bonusa na podlagi uspenosti, odvisno od doloenih parametrov uspenosti.Nagrade, ki jih prinaa lanstvo v nai ekipi, segajo dale preko osnovne plae in spodbud. Ponujamo tudi razline konkurenne ugodnosti v naravi, ki vam pomagajo uspevati osebno in poklicno, kot so zavarovalni narti, pokojninski narti, viri za dobro poutje in globalni programi priznanja. Poleg tega ponujamo prilagodljive in hibridne monosti dela, kjer je mogoe, ter najmanj 14 tednov plaanega starevskega dopusta.

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-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)

Primary location salary range

€75,880.00 - €140,920.00

Division

Development

Business Unit

Quality

Location

Slovenia

Site

Menge

Company / Legal Entity

SI19 (FCRS = SI019) Novartis farmacevtska proizvodnja d.o.o.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

Accessibility and accommodationNovartis 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.

Quality Development Slovenia

Job ID

REQ-10083507

Director, Global TRD QA Sterility Assurance

Apply to Job

Job ID

REQ-10083507

Director, Global TRD QA Sterility Assurance

Apply to Job