Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on global level.
Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process.
Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents.
Drive and support comprehensive root cause investigations and the development of corrective and preventive actions plans and lessons learned related to escalated GxP and Quality incidents.
Ensure that the activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry; prepare for and support inspections and audits.
Develop and deliver training on incident management procedures and promote a culture of quality and accountability across the organization.
Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.

Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry
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

Key skills