Country Quality Manager & Qualified Person

About the role

The Country Quality Manager & Qualified Person ensures that products, processes and procedures comply with GxP and local specifications, and that production activities align with Novartis quality policy and regulatory requirements.

Key responsibilities

• Implement and maintain a local Quality Management System in line with Novartis Quality Manual and local regulations.
• Act as Qualified Person for the Farmanova entity, performing batch release checks and approving products.
• Manage product recalls, mock recalls, and support related activities.
• Lead investigations of quality deviations, complaints and ensure CAPA implementation.
• Review and approve SOPs, manage change control and serve as Change Management Lead.
• Conduct quality system and GMP audits, lead training and self‑inspection activities.
• Oversee vendor management, third‑party warehouse quality, and maintain ISO 9001:2015 compliance.
• Prepare and report quarterly Key Quality Indicators, annual quality plans and review reports.

Required profile

• University degree in Pharmacy, Chemical Engineering, Chemistry or related field.
• Minimum 6 years of quality experience in the pharmaceutical industry, including at least 2 years at a manufacturing site.
• Strong knowledge of local regulatory requirements, cGMP, GxP and pharmaceutical distribution processes.
• Excellent English communication skills and ability to manage multiple priorities.

Required skills

• GxP, GMP, GDP compliance
• Batch release and Qualified Person responsibilities
• CAPA, change management, audit and risk management
• ISO 9001:2015 Quality Management System
• Vendor qualification and supplier management