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

About this role

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.
• ​
• We offer
• permanent employment
• with
• 6
• months
• of
• probation period.
• Submit your application with the CV in Slovenian and English language.
• 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
• (We
• ll-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.
• Skills Desired
• Audit Management, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management, People Management and Leadership, Product Release, Qa (Quality Assurance), Self-Awareness, Technological Expertise