Quality Assurance Senior Specialist

About the role

The Quality Assurance Senior Specialist ensures that all controlled‑drug activities comply with Saudi Food and Drug Authority (SFDA) regulations and Good Distribution Practices (GDP). This role leads inventory control, regulatory liaison, investigations and continuous improvement initiatives.

Key responsibilities

• Manage custody and inventory of controlled drugs in company and SFDA systems.
• Serve as primary contact with the SFDA for inquiries, reporting, system management and stock accountability.
• Liaise with Commercial, Planning and Customer teams on controlled‑drug sales requests.
• Handle quality deviations and customer complaints, conduct investigations, root‑cause analysis and implement CAPA.
• Obtain import permits and oversee product clearance through the SFDA system.
• Supervise preparation and distribution of controlled drugs, ensuring inventory accuracy.
• Prepare and maintain documentation for internal and external quality audits.
• Conduct quality awareness training on GDP and quality standards.
• Support risk assessments and recommend corrective actions.
• Drive continuous‑improvement projects for QA operations.
• Monitor warehouse safety and report deviations.
• Coordinate product recall activities with SFDA and suppliers.

Required profile

• Bachelor’s degree in Pharmacy, Quality Management, Life Sciences or related field.
• Minimum 4 years of Quality Assurance experience, preferably in pharmaceutical or healthcare.
• Familiarity with warehouse operations and Good Distribution Practices.
• Experience with SFDA regulations and systems is preferred.
• Strong analytical, problem‑solving and project‑management abilities.
• Excellent organizational skills and attention to detail.
• Working proficiency in Arabic and English.

Required skills

• Microsoft Office applications (e.g., Excel, Word, PowerPoint).
• Reporting dashboards.