Experteer Overview
In this Site Quality Head role, you shape and safeguard the quality strategy for a complex Ivrea manufacturing site. You partner with site and global leadership to ensure compliant operations, continuity, and innovative improvements. You drive a strong quality culture while supporting launches and ensuring every product release meets safety and regulatory standards. You will lead a multidisciplinary quality organization and be pivotal in Health Authority engagements. This position offers high-visibility impact and strategic influence.
Retribuzione / Benefits
- Lead the site Quality strategy to ensure full cGMP and regulatory compliance with corporate standards
- Establish and sustain a governance model and decision-making framework for the site quality organization
- Own and manage site quality systems including deviations, investigations, change control, PQ reviews, and documentation lifecycle
- Ensure inspection readiness and coordinate Health Authority inspections and follow-ups
- Act as Qualified Person (Deputy) overseeing batch certification and release per legal requirements
- Drive quality risk management, escalation processes, and timely health authority notifications
- Cultivate a strong quality culture through training, self-inspections, and continuous improvement initiatives
- Provide leadership input for talent development, succession planning, and launch readiness
- Lead and develop quality leaders and teams to sustain performance and regulatory excellence
Responsabilità
- Bachelor's degree in a scientific discipline
- Minimum five years of experience in pharmaceutical Quality Assurance or Quality Control in a regulated manufacturing environment
- Strong knowledge of cGMP and pharmaceutical quality management systems
- Proven experience leading quality organizations with people management and performance oversight
- Demonstrated experience preparing for, hosting, and responding to Health Authority inspections
- Fluent English, written and spoken, in global cross-functional contexts
