About this role

Managing assigned escalated GxP and Quality incidents in an end-to-end process on global level
Initiating GxP/Quality incident prevention measures
Maintaining (incl continuous improvement) of defined incident management related processes within regulated environments on global level
Leading and overseeing that quality incidents are managed effectively
Ensuring compliance with regulatory requirements (e.g., ICH Q9)
Building and growing the knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle

Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices)
Master’s degree and 10+ years direct experience preferred
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Experience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management

Key skills