Expert, Drug Supply Management (m/f/d) - Ekspert za oskrbo zdravil (m/f/d)
PharmaRegulatory AffairsQuality Assurancegmpcrosap
Job description
Salary Range: €27,160.00 - €50,440.00 Job Description Summary We are thrilled to announce the establishing of new clinical manufacturing facility in Slovenia, dedicated to accelerating the creation of innovative medicines for patients around the globe. Don’t miss the chance to join our international team. As Expert Drug Supply Management you will be part of our Drug Product Clinical Manufacturing Team at our Technical Research and Development site in Menges, Slovenia and be primarily responsible for Clinical Manufacturing Plant. Z veseljem napovedujemo ustanovitev novega obrata klinične proizvodnje v Sloveniji, namenjenega hitrejšemu odkrivanju inovativnih zdravil za bolnike po vsem svetu. Ne zamudite priložnosti, da se pridružite naši mednarodni ekipi. Kot Ekspert za oskrbo boste del ekipe za klinično proizvodnjo na naši lokaciji za tehnične raziskave in razvoj v Mengšu, kjer boste v prvi vrsti odgovorni za obrat klinične proizvodnje. #LI-Hybrid Location – Mengeš, Slovenia Job Description Key Responsibilities : Contributing to the Material Management Process for Clinical Manufacturing Support preparation of material Specification, Coordinate filling out the MARF template, support preparation of GLIMS CAD, Support incoming goods inspection and Release of Material Monitor Supplier Qualification and Support Vendor Management Monitor material status in SAP system Lead deviations and Root cause investigations in Clinical Manufacturing related to Materials Support Business Continuty by assessing and supporting the establishment of second vendors Co-creating SOP landscape within NVS and implementation of SOP according to Clinical Drug Product Manufacturing requirements and specifics Onboarding and mentoring of associates in area of drug supply Providing technical expertise during regulatory inspections and ensuring compliance with regulatory requirements. Cross-Functional Collaboration in and outside the organization to align activities with organizational goals, specifically Quality Assurance and Vendors Essential Requirements: Accountability: responsibility for assigned tasks and reliability. Decision Making: correct interpretation of analyses and evaluations and identifying appropriate measures to be taken. Ability to work in a team (constructive and reliable contribution in a group setting) and in a matrix environment. Influencing without authority. Results driven self-motivation and motivation of others to achieve outstanding results while ensuring adherence to ethical and legal principles, with a continuous drive for improvement. Quality focus: providing the highest quality products and services that meet the needs and requirements of internal and external customers. 3 years of experience in supply organizations; thorough knowledge of GMP requirements. We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language. 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: Slovenia: €27,160 – 50,440 The 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. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. In addition to your base salary, you will be eligible for benefits listed below: Annual bonus for all employees: 10% of annual base salary. Holiday allowance: In 2025 it amounted to €2,496 (net). For 2026 it amounts to €2,678.28 (net). Yearly performance-based bonus: In 2025 it amounted to €2,538.64 (gross), including the winter allowance. Voluntary supplementary pension insurance: Novartis in Slovenia provides voluntary supplementary pension insurance (5.844% of gross salary, capped annually at €3.224,18). Shift allowances: shift work (15%); multi-shift work (20%); night work (70%); work on Sundays and public holidays (50%). (if selected candidates will work in shifts) Insurance: Additional accident insurance: During employment at Novartis, the employee is insured 24/7 in the event of death or disability resulting from an accident. Specialist insurance: Group health insurance providing faster access to specialist healthcare services at Triglav Health Insurance Company d.d. for you and your family members. Care Connect: A program offering confidential, personalized support for mental health and well-being through therapy, counselling, tools, and more. Other benefits in accordance with legislation and collective agreements: Transportation, meal allowance, and other supplements. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process. 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. Vaše ključne odgovornosti: Zagotavljanje procesa upravljanja materialov za klinično proizvodnjo. Priprava ocene tveganja za nov material s kategorizacijo materiala, priprava specifikacije naročanja, usklajevanje izpolnjevanja predloge MARF, sprožitev nakupa, priprava končne specifikacije, sprožitev in spremljanje načrtov vzorčenja, spremljanje sproščanja materiala. Spremljajte kvalifikacijo dobavitelja in podpora za upravljanje dobaviteljev. Spremljanje statusa meteriala v SAP sistemu. Preiskave glavnih vzrokov odstopanj v klinični proizvodnji, povezane z materialom. Podpiranje neprekinjenega poslovanja z ocenjevanjem in podpiranjem upeljevanja alternativnih ponudnikov. Soustvarjanje okolja SOP v NVS in izvajanje SOP v skladu z zahtevami in posebnostmi klinične proizvodnje. Vključevanje in mentorstvo sodelavcev na področju oskrbe zdravil. Zagotavljanje tehničnega strokovnega znanja med regulativnimi inšpekcijskimi pregledi in zagotavljanje skladnosti z regulatornimi zahtevami. Medfunkcionalno sodelovanje v organizaciji in zunaj nje za uskladi
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