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Head of Quality Systems and Risk Management

EUSA Pharma

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
Offerta di lavoro pubblicata 2 mesi fa