Sr. Manager QA APL & GEM EMEA
Core
Lead Quality related activities at the country/cluster level, ensuring compliance with regulatory standards and quality system requirements for APL and Representative Offices.
Role type
Senior Manager, Quality Assurance (Medical Device/Pharma)
Builds
Quality oversight for APL and Representative Offices
Domain
Medical Device / Pharmaceutical / Regulatory Affairs
Required skills
Quality Management System (QMS) implementation, ISO 13485, EU-MDR, GDP, CAPA, risk management, audit management, supplier qualification, market actions (recalls), root cause analysis, people management
Preferred skills
Supply Chain experience, finished product distribution experience
Technologies
ISO 13485, EU-MDR, GDP
Responsibilities
Promote Quality Culture and regulatory awareness; Lead QA personnel through training and performance reviews; Act as Quality Management Representative to establish and maintain QMS; Ensure product compliance with market authorization and GMP; Manage non-conformance investigations and corrective actions; Lead audit preparation and close out external audits; Manage market actions and report to Health Authorities; Ensure GxP supplier qualification and monitoring.
Seniority
Senior, hands-on IC with management responsibilities