Network Quality Assurance Manager

The Position

The role champions a culture of quality throughout the FWC Africa markets by leading a robust quality assurance program, ensuring strict compliance, and effectively managing any emergent quality and product safety issues.

Main Responsibilities

• Network quality management review: Reporting on quality performance, monitoring Quality-KPIs, and conducting management reviews per ISO 13485 requirements.
• Quality system management: Managing the QMS, ensuring adherence to international standards and Roche policies, and facilitating training on quality processes.
• Management of External Business Partners: Overseeing the quality lifecycle of partners, including supplier qualification, contract management, and 3PL operations oversight.
• Risk management: Integrating Quality Risk Management into business processes and conducting annual risk evaluations.
• Change control: Ensuring compliance with change control processes for planning and implementing changes.
• Document control: Managing document management systems, maintaining SOPs and policies, and ensuring timely approval workflows.
• Operational QA management: Overseeing logistics, shipment, product integrity, and cold chain management.
• Local Safety Officer: Overseeing complaint management system compliance and case quality reviews.

Who you are

Required Experience and Education: Bachelor’s degree in a health science related field, bilingual in English and French, 2-3 years of experience in the medical device/IVD industry, and 2-3 years of management experience. Must have knowledge of pharmaceutical regulations and QA principles.

Required Competencies and Skills: Achieving results, strategic agility, political savvy, relationship management, teamwork and collaboration, communication, problem solving, and situational responsiveness.