Quality Control Head

Key responsibilities:

• Certify that each batch of manufactured drugs agrees with the current applicable laws and with drug marketing authorizations or investigational medicinal product dossier.
• Ensure compliance with the rules of hygiene and safety and protection according to Legislative Decree 81/2008
• Full end-to-end responsibility, ownership and accountability for the whole process from sample receipt to result release (including ownership of the equipment).
• Together with the Site Quality Head and the Leadership Team, QC Head formulates strategies and makes decisions which ensure the efficient and compliant operations of Saluggia Site.
• Writes and/or approves laboratory relevant SOPs and reviews guidelines, Quality Modules, and all analytical work-related documentation.
• Ensures that lab operations are following a compliant processes including a high degree of Data Integrity assurance.
• Partners with the Site Quality Head to establish budgets and manages operating expense budget in laboratory area.
• Ensures that all activities are performed according to the local Quality system and SOPs.
• Ensures that appropriate corrective / preventative actions are defined and implemented in due time.
• Supports internal audits and external inspections, according to the Novartis Corporate Quality Manual and supports / participates in NEM cases as required.
• Drives lab objectives by providing leadership, direction and support to the team members and ensuring that they are adequately qualified and trained to achieve a high level of competence and are motivated to excel.
• Actively works at retaining and developing talents, identifying and responding to their technical and interpersonal development needs.

Essential requirements:

• Scientific Degree (CTF, Pharmacy or Chemistry preferred).
• Previous experience in a leadership role within a laboratory of a pharmaceutical company.
• Knowledge of Quality System and GMP requirements, analytical technology and equipment, incl. qualification and calibration.
• Fluent in Italian and English.

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-culture

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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.