International Quality Management professional with a highly organized, proactive, transparent-multicultural- diversity team-oriented mentality that will assure company processes are in compliance with Good Clinical Practice (GCP) and applicable regulations within tight deadlines.Experienced Leader with ability to lead with/without authority.Proven ability:⬥︎ Project/People ManagementBuilding effective relationships ⬥︎ Team leadership: leading team of 8 QA operators ⬥︎ Change Management ⬥︎ Customer-centric thinking with international effective communication ⬥︎ Good Clinical Practice (GCP) & compliance⬥︎ Documentation Management, Good Documentation Practice (GDP) & compliance⬥︎ Execution of successful sponsor/internal/vendor audits ⬥︎ Document and training management, training/development of personnel.⬥︎ Driven to ensure standards are met along with a can-do, helpful, respectful, collaborative, and hands-on approach ⬥︎ Good knowledge of GDPR (General Data Privacy Regulations) ⬥︎ Risk analysis/root cause and documentation of deviations ⬥︎ Quality Management Systems (QMS) and training compliance⬥︎ CAPA management, complaint management, client/internal/vendor auditing⬥︎ Writing and maintenance of standard operating procedures, policies and work instructions ⬥︎ Software validation quality review ⬥︎ Highly organized, proactive, punctual, team-oriented mentality (transparent, multicultural, diversity spirit) ⬥︎ Excellent troubleshooting skills to manage QA standards and meet tight deadlines ⬥︎ Multilingual with fluency in Dutch, French and English ⬥︎ Experience with Microsoft Office ⬥︎ Experience with several Quality Management Systems (Master Control, TMS Web, Sharepoint)