Vodja upravljanja kakovosti - operacije (m/ž/d) / QA Operations Lead (m/f/d)

Vaše ključne odgovornosti:

• Zagotavljanje skladnosti vseh aktivnosti z veljavnimi cGxP standardi ter skrb za dosledno in pravilno izvajanje kakovostnih procesov na lokaciji.
• Vodenje in podpora pri GxP presojah ter inšpekcijah regulatornih organov, vključno s pripravo dokumentacije in koordinacijo vseh aktivnosti na lokaciji.
• Vodenje ekipe upravljanja kakovosti – operacije na lokaciji, z odgovornostjo za pravočasne, strokovne in skladne odločitve na področju QA.
• Pregled in odobritev glavnih proizvodnih zapisov (Master Batch Records - MBR) ter zagotavljanje njihove pravilnosti, sledljivosti in skladnosti z regulativnimi zahtevami.
• Koordinacija sproščanja izdelkov v skladu z globalnimi in lokalnimi regulativami, internimi postopki ter pričakovanji trga.
• Spodbujanje operativne odličnosti z uvajanjem najboljših praks, optimizacijo procesov ter krepitvijo kulture nenehnih izboljšav.
• Učinkovito upravljanje operativnih stroškov oddelka za upravljanje kakovosti – operacije ter aktivno iskanje priložnosti za racionalizacijo procesov brez vpliva na skladnost ali kakovost.

Vaš doprinos k delovnem mestu:

• Univerzitetna izobrazba iz farmacije, biologije, kemije, mikrobiologije ali druge ustrezne naravoslovne oziroma tehniške smeri.
• Najmanj 5 let izkušenj na področju kakovosti, proizvodnje ali primerljivih delovnih mest.
• Odlično poznavanje cGxP, EU/FDA regulative in mednarodnih standardov.
• Dokazane vodstvene sposobnosti ter izkušnje z razvojem ekip.
• Sposobnost vodenja presoj, inšpekcijskih pregledov in procesov sproščanja izdelkov.
• Tekoče znanje angleškega jezika.

Key Responsibilities

• Ensure compliance with all activities in line with applicable cGxP standards and oversee the consistent and correct execution of quality processes at the site.
• Lead and support GxP audits and inspections by regulatory authorities, including preparation of documentation and coordination of all site activities.
• Lead the Quality Operations team at the site, with responsibility for timely, expert, and compliant decision‑making within QA.
• Review and approve Master Batch Records (MBR) and ensure the accuracy, traceability, and regulatory compliance of production documentation.
• Coordinate product release in accordance with global and local regulations, internal procedures, and market expectations.
• Drive operational excellence by implementing best practices, optimizing processes, and strengthening a culture of continuous improvement.
• Effectively manage operational costs within Quality Operations and proactively identify opportunities for process optimization without compromising compliance or quality.

Key Qualifications

• University degree in Pharmacy, Biology, Chemistry, Microbiology, or equivalent natural or engineering science.
• Minimum 5 years of experience in Quality, Manufacturing, or comparable positions.
• Strong understanding of cGxP, EU/FDA regulations, and international standards.
• Demonstrated leadership and team development skills.
• Ability to manage audits, inspections, and product release processes.
• Fluent proficiency in English.

Benefits and Rewards:   

Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (Well-being), 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.