About the role :

Location: Mengeš, #LI-Hybrid.

We bring life-saving medicines to millions of people. We are at the crossroads of the latest advances in medical science and innovative digital technology. Everything we do is in line with our commitment to quality and to providing safe active substances for patients. Our commitment to quality is based on science, we innovate and our work is patient-centered. Whether you are involved in development, production, maintenance, compliance or analysis, your contribution will have a direct impact on patients. " Without quality checks and quality assurance at all points in the process, we cannot reliably build patient trust. Do you value this mission?

As the Quality Team Leader QA Operations department, you will be responsible to lead and support our QA Experts and Specialists team and coordinate operational activities. You will ensure compliance with all cGxP, regulatory, HSE aspects and implementation of the expert knowledge, skills and process optimization.

Key Responsibilities:
• Coordination the group of expert and specialist and their operational activities.
• Support projects for introduction of new products into production, implementation of new equipment, improvements and increases in the capacities of production processes and validation studies. New equipment qualification support (Performance Qualification - PQ).
• Track team metrics and ensure Key Performance Indicators (KPI) / Key Quality Indicators (KQI) meet requirements. Resource and capacity planning and workload management.
• Participate in development, implementation and controlling of the quality system in accordance with Slovenian, EU laws, Food and Drug Administration (FDA), international guidelines for production of medicines and Novartis standards.
• Internal and external auditing of the quality system, conduct of inspections and customer audits. Responsibility for deviation, complaints, and change management.
• Ensure release of product batches in accordance with Slovenian, EU laws, markets where product batches are released, internal Novartis standards and contracts with partners.
• Creation and approval of technical and technological documentation, approval of product and process validations, change requests, support of qualification of new technological equipment.
• Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements.