16 ott - Parma
Chiesi
Overview In this role, you will lead Global Quality Operations to harmonize quality across manufacturing sites and laboratories. You will drive continuous improvement, oversee quality topics, and ensure compliance with GMP and regulatory standards. You will collaborate with site Quality Directors and Compliance teams to align processes and prepare for inspections. This position offers leadership scope across multiple sites from Parma, with a focus on building a culture of quality excellence and cross-site coordination.
Retribuzione / Benefits
company car pension private medical insurance wellbeing programme flexible benefits programme relocation support
Responsabilità
Oversee and harmonize quality operations across all sites to ensure product quality and adherence to Quality KPIs Establish and enforce validation guidelines for systems and processes per GMP regulations Supervise validation processes, draft and review Validation Project Plans and Final Reports, set timelines, and coordinate corrective actions Coordinate cross-site quality efforts with site Quality Directors,
support business continuity assessments, and facilitate Corporate/Local Quality Council activities Collaborate with Compliance to meet internal and regulatory requirements and prepare for inspections Provide strategic leadership to foster a culture of quality excellence across the organization
Requisiti fondamentali
Degree in scientific disciplines Minimum 15 years of pharmaceutical quality assurance experience with at least 10 years in a leadership role Deep understanding of quality management systems, compliance standards, and regulatory requirements (EMA, FDA, etc.) Experience with EU, US, and rest of world regulatory authorities Strong leadership and people management Excellent communication and relationship-building skills Strategic thinking and ability to influence cross-functional teams Quality management systems (QMS) expertise GMP regulatory requirements and inspections experience Validation governance, validation project planning and reports
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