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The Regional Quality Manager is responsible for leading and maintaining quality systems and performance across multiple sites within an assigned region. This role ensures compliance with applicable regulatory, customer, and internal requirements while driving continuous improvement, risk reduction, and a strong quality culture. The position partners closely with Operations, Engineering, Regulatory, Supply Chain, and other cross-functional teams to support business objectives and product integrity. This position will also collaborate heavily with other quality professionals within the organization to identify global risks and opportunities.
Job Responsibility:
Oversee regional implementation and effectiveness of the Quality Management System (QMS) in alignment with corporate standards and applicable regulations
Ensure consistent application of quality policies, procedures, and work instructions across all sites in the region
Monitor regulatory and standards changes and assess regional impact
Lead preparation and execution of internal, external, customer, and regulatory audits
Support site teams during customer inspections and act as a regional point of contact for quality-related findings
Ensure timely and effective responses to audit observations, including root cause analysis and corrective actions
Oversee regional CAPA processes to ensure effective investigation, root cause determination, and sustainable corrective actions
Track CAPA trends and performance metrics
escalate risks as needed
Define, monitor, and report regional quality KPIs
Drive continuous improvement initiatives using risk-based and data-driven approaches
Share best practices and lessons learned across sites to improve consistency and performance
Provide leadership, coaching, and mentoring to site quality teams
Partner with Operations, Engineering, Regulatory, Supply Chain, Finance, and PMO to support new product introductions, process changes, and issue resolution
Foster a strong quality mindset and accountability throughout the region
Support resolution of significant customer quality issues and complaints
Represent the region in corporate quality forums and management reviews
Requirements:
7+ years of progressive experience in quality management within a regulated or manufacturing environment
Experience managing quality systems across multiple sites or locations
Strong knowledge of QMS, audits, CAPA, and continuous improvement methodologies
Demonstrated leadership and ability to influence cross-functional teams
Familiarity with digital QMS tools and data-driven quality reporting