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Site Quality Head

Experteer Italy

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
#J-18808-Ljbffr
Offerta di lavoro pubblicata 2 giorni fa
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