Head of Quality Systems and Risk Management
2 giorni fa
varese, lombardy, Italia
EUSA Pharma
Tempo pieno
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Overview
As Manager, you will lead global QMS and QRM governance across manufacturing, labs, supply chain, and partners to ensure compliance, patient safety, and product quality. You will act as the corporate process owner for quality systems and drive continuous improvement, inspection readiness, and data integrity. Join a cross-functional, multinational team to align quality objectives with business goals and support acquisitions and harmonization efforts. Your work shapes quality culture and ensures robust risk-based decisions at scale.
Responsabilità Govern global QMS and ensure effectiveness of quality elements (Deviations, CAPA, Change Control, Complaints, Management Review)
Drive quality metrics, analytics and system trending
Establish standards for APR/PQR processes
Lead enterprise Data Integrity strategy and oversight
Govern Supplier Quality requirements and performance monitoring
Lead inspection readiness programs and support major health authority inspections
Establish global risk-based auditing program
Support acquisitions, integrations and global harmonization programs
Requisiti fondamentali Bachelor degree in Pharmacy, Chemistry, Engineering, Microbiology or related discipline
12–15 years of progressive pharmaceutical quality experience with global leadership
Expert knowledge of QMS governance, risk management, compliance, and cross-functional leadership
cross-functional leadership
stakeholder influence
change leadership
QMS governance
Quality Risk Management (QRM)
Data Integrity
As Manager, you will lead global QMS and QRM governance across manufacturing, labs, supply chain, and partners to ensure compliance, patient safety, and product quality. You will act as the corporate process owner for quality systems and drive continuous improvement, inspection readiness, and data integrity. Join a cross-functional, multinational team to align quality objectives with business goals and support acquisitions and harmonization efforts. Your work shapes quality culture and ensures robust risk-based decisions at scale.
Responsabilità Govern global QMS and ensure effectiveness of quality elements (Deviations, CAPA, Change Control, Complaints, Management Review)
Drive quality metrics, analytics and system trending
Establish standards for APR/PQR processes
Lead enterprise Data Integrity strategy and oversight
Govern Supplier Quality requirements and performance monitoring
Lead inspection readiness programs and support major health authority inspections
Establish global risk-based auditing program
Support acquisitions, integrations and global harmonization programs
Requisiti fondamentali Bachelor degree in Pharmacy, Chemistry, Engineering, Microbiology or related discipline
12–15 years of progressive pharmaceutical quality experience with global leadership
Expert knowledge of QMS governance, risk management, compliance, and cross-functional leadership
cross-functional leadership
stakeholder influence
change leadership
QMS governance
Quality Risk Management (QRM)
Data Integrity