Quality Control Head

Novartis Contract Manufacturing; Saluggia; In loco; EUR 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Saluggia is seeking a Quality Control Head to lead the QC team responsible for compliance and quality assurance in drug manufacturing. The role involves strategic planning, team development, and ensuring laboratory operations align with regulatory requirements. Ideal candidates should have a relevant scientific degree and extensive leadership experience in a pharmaceutical lab environment. Fluency in Italian and English is required.

Competenze

• Previous experience in a leadership role within a laboratory of a pharmaceutical company.
• Knowledge of Quality System and GMP requirements, analytical technology and equipment.
• Fluent in Italian and English.

Mansioni

• Ensure compliance with laws and drug marketing authorizations.
• Manage the end-to-end process from sample receipt to result release.
• Write and approve laboratory SOPs and review analytical documentation.
• Ensure all activities are compliant with local Quality system and SOPs.
• Provide leadership and support to team members.

Conoscenze

Leadership

Data Integrity

Quality Management

Analytical Technology

Communication

Formazione

Scientific Degree (CTF, Pharmacy or Chemistry preferred)

Descrizione del lavoro

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.

About The Role

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.

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.