Quality Control Head

Job Description Summary

The Quality Control Head leads Saluggia Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives and people training and development.
The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and Key Performance Indicators (KPI), specifically related to Compliance and Quality-related topics.

Job Description

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. 

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Managing Resources, Organizational Savvy, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Smart Risk Taking, Technological Expertise, Total Quality Management