Director, Quality Operation
Pubblicato il 21-08-2026 - Altro in Italia
Experteer Overview In this role you lead Quality Operations, Compliance and Batch Release at the Ferentino site, ensuring cGMP compliance and inspection readiness. You will partner with customers, regulators and cross‐functional teams to drive quality excellence and continuous improvement. You shape the quality culture, oversee risk management and critical quality decisions, and guide QP activities and lifecycle quality oversight. This is a strategic leadership role with a meaningful impact on patient safety and regulatory outcomes.
Retribuzione / Benefits Provide strategic leadership for Quality Operations, Compliance & Batch Release
Ensure ongoing regulatory compliance (cGMP, FDA, EMA, MHRA) and inspection readiness
Lead regulatory inspections and customer audits; act as primary quality representative for critical matters
Oversee product disposition, batch certification, investigations, deviations, CAPAs, change controls, complaints and risk management
Support Qualified Person (QP) activities and lifecycle quality oversight
Drive risk-based quality review and escalation to mitigate issues
Serve as trusted quality partner to customers and regulators; govern quality agreements
Support regulatory submissions, inspections, and responses to observations; guide technology transfers and product launches
Lead continuous improvement initiatives across manufacturing, lab, and supply chain; promote digital quality initiatives
Develop and coach high‐performing quality teams; foster accountability and collaboration across functions
Responsabilità Advanced Degree with 6+ years of experience, or Bachelor's Degree with 8+ years in a regulated pharmaceutical, medical device, biologics, diagnostics, or related industry
Degree in Life Sciences, Engineering, Chemistry, Pharmacy, or related discipline
Minimum 5 years of leadership experience within Quality organizations
Strong knowledge of cGMP, FDA regulations, EU GMP and global quality standards
Proven experience leading regulatory