Quality ESO FDF Head

About the role

The Quality ESO FDF Head leads the ESO Quality function for final drug products, overseeing Quality Assurance Managers and ensuring that all operational activities comply with current Good Manufacturing Practice (cGMP), legal regulations, and Novartis quality policies.

Key responsibilities

• Manage, support and monitor third‑party service providers and license holders, ensuring resource availability and effectiveness.
• Track regulatory updates, industry trends and technological advances to maintain cGMP compliance.
• Address quality and technical issues with external suppliers according to Novartis and global standards.
• Prepare, maintain and review quality agreements, defining clear roles, responsibilities and requirements.
• Define quality strategy, planning and risk management for external supply, including risk assessments, CAPA actions and mitigation of unacceptable risks.
• Oversee escalation, investigation and resolution of critical quality matters such as complaints, recalls, falsifications and stability deviations.
• Represent quality in external supplier management, project transfers, launches, audits and regulatory inspections.
• Lead, develop and train teams, monitor key performance indicators and foster positive relationships with internal functions, suppliers and business partners.

Required profile

• University degree or PhD in biological sciences, pharmacy, medicine or a related field.
• Active knowledge of English.
• Minimum five years of experience in the pharmaceutical industry.
• Experience in quality assurance, quality control, drug registration or manufacturing.

Required skills

• Proficiency with Microsoft Office.