The Healthcare Quality Assurance Strategic Quality Lead and Qualified Person is responsible for managing the Marken and Polar Speed Quality Management System to ensure compliance with regulatory and client expectations
Job Summary
The Healthcare Quality Assurance Strategic Quality Lead and Qualified Person is responsible for managing the Marken and Polar Speed Quality Management System to ensure compliance with regulatory and client expectations.
This role involves hosting regulatory inspections, managing audit responses, and providing quality leadership across multiple locations within the assigned region.
The position supports growth of new and expanded facilities, clients, and services while maintaining effective quality performance monitoring and communication.
Matching Summary
The Healthcare Quality Assurance Strategic Quality Lead and Qualified Person is responsible for managing the Marken and Polar Speed Quality Management System to ensure compliance with regulatory and client expectations.
Skills & Requirements
Must-have
Quality Management System oversight
GMP/GDP regulatory compliance
Qualified Person certification
Regulatory inspection hosting
Audit program preparation
Quality leadership and team oversight
Nice-to-have
Experience with investigational medicinal products
Client liaison on QP matters
Support for production and manufacturing
Quality performance monitoring and reporting
Key Requirements
Bachelor's degree in Sciences
Qualified Person under Human Medicines Regulations 2012