Quality Assurance Executive

About the role

The Quality Assurance Executive will lead the implementation and maintenance of QA processes that support clinical supply chain operations. This role ensures that all documentation, SOPs and quality manuals meet regulatory and certification requirements.

Key responsibilities

• Develop, review and update SOPs, quality manuals and related documentation.
• Conduct internal quality audits and support vendor and supplier audits.
• Monitor corrective and preventive actions to drive continuous improvement.
• Coordinate with operations and project teams to ensure compliance with ISO and GDPMDS standards.
• Manage quality records, support QA training, and prepare periodic quality reports and metrics for management.

Required profile

• Strong background in Quality Assurance and Quality Management, including system development and monitoring.
• Experience in Quality Control activities such as inspections, testing and process monitoring.
• Proven ability to plan and execute internal audits and support external/regulatory audits.
• Bachelor’s degree in science, pharmacy, engineering or a related field.
• Prior experience in quality functions within healthcare, pharmaceutical, clinical research or medical devices is advantageous.
• Knowledge of ISO standards and good documentation practices with high attention to detail.

Required skills

• ISO 9001
• ISO 13485
• ISO 27001
• Quality Auditing
• Quality Control
• SOP development