Emirates Drug Establishment is looking for an experienced Expert Inspector – Good Practices (GxP) to strengthen its inspection capability across pharmaceutical, biological, and medical-product operations in the UAE. This is a senior regulatory role for someone who combines technical depth with sound judgment, and who wants to help safeguard the quality, safety, and compliance of regulated health products. As Expert Inspector, you’ll plan and conduct risk-based GxP inspections, audits, and follow-up activities; assess compliance with UAE requirements and internationally recognized standards, including PIC/S guidance where relevant; review facilities, quality systems, manufacturing operations, computerized systems, validation, engineering controls, and corrective-action plans; prepare clear inspection reports and identify compliance gaps; recommend appropriate regulatory actions; and support the development of inspection procedures, technical guidance, and inspector capability. Specialists with experience in biologics and ATMP manufacturing, sterile manufacturing, pharmaceutical engineering, computerized systems, GCP, or medical-device GxP inspection are sought.
About Emirates Drug Establishment — UAE Medicines Regulator
Employer: Emirates Drug Establishment (EDE)
Location: Dubai, United Arab Emirates
Function: Licensing, control, and inspection of pharmaceutical and medical products
Scope: Pharmaceutical, biological, and medical-product operations
Standards: UAE requirements, PIC/S guidance, and recognized GxP principles
Expert Inspector Role — Good Practices Regulatory Inspection
Department: Licensing & Control / Inspection
Primary Focus: Risk-based GxP inspections, audits, and compliance assessment
Scope: Pharmaceutical, biologics, sterile, clinical, and medical-device operations
Mission: Safeguarding the quality, safety, and compliance of regulated health products
Expert Inspector Position Overview
The Expert Inspector – Good Practices role sits within the regulator’s licensing and control function, where inspection judgment protects patients and the public. You’ll plan and carry out risk-based inspections, audits, and follow-up visits across pharmaceutical, biological, and medical-product operations. Each inspection starts with preparation: understanding the site, its products, and the risks that matter most, so that time is focused where it counts. On site, you’ll review the full picture, including facilities and equipment, quality systems, manufacturing operations, computerized systems, validation records, engineering controls such as HVAC and cleanroom systems, and the corrective-action plans a company has put in place. Assessing compliance means measuring what you find against applicable UAE requirements and internationally recognized standards, and PIC/S guidance where it applies. Clear reporting is essential. You’ll prepare inspection reports that describe compliance gaps precisely, and recommend regulatory actions that are proportionate and well grounded. Beyond individual inspections, you’ll help develop the inspection procedures and technical guidance that guide the wider team, and you’ll contribute to building inspector capability across the organization. Specialist knowledge is valued in areas such as biologics and advanced therapy medicinal products, sterile manufacturing, pharmaceutical engineering, computerized systems, GAMP 5, good clinical practice, and biomedical engineering.
As Expert Inspector, you’ll deepen your command of GMP, GDP, GCP, and GAMP 5, sharpen your judgment in complex regulatory situations, and work alongside colleagues who share a commitment to public health. The ideal candidate holds a bachelor’s or master’s degree in pharmacy, pharmaceutical sciences, biotechnology, biomedical engineering, chemical or pharmaceutical engineering, IT or software engineering, or a related discipline. Strong experience in pharmaceutical, biologics, ATMP, sterile-product, clinical-research, medical-device, or regulatory inspection environments is essential, and practical knowledge of the major GxP standards is expected. Formal inspector or auditor certification is preferred, and GCP auditor certification is required for candidates applying for the GCP specialism. Exposure to PIC/S inspection principles is strongly preferred. Excellent report writing, stakeholder management, and professional English communication are required, and Arabic is an advantage. For regulatory professionals in the UAE who want to shape pharmaceutical quality at a national level, this role offers meaningful and highly technical work.
Why This Role Matters: As Expert Inspector at Emirates Drug Establishment, you help make sure the medicines and medical products reaching patients in the UAE meet rigorous quality standards, apply risk-based inspection judgment in complex manufacturing settings, shape the procedures and guidance that guide inspections nationwide, build inspector capability, and advance a senior career in pharmaceutical regulation.
Key Responsibilities & Inspection Duties
Risk-Based Inspection Planning
- Plan risk-based GxP inspections
- Prioritize sites and activities by risk
- Prepare inspection scope and checklists
- Review previous inspection history before visits
- Schedule audits and follow-up activities
- Coordinate inspection logistics with the team
Inspection & Audit Execution
- Conduct GxP inspections and audits on site
- Carry out follow-up inspections to verify corrective actions
- Interview personnel across quality and production
- Observe manufacturing and operational practices
- Assess facility and equipment condition
- Document observations accurately during visits
Compliance & Systems Assessment
- Assess compliance with UAE requirements
- Apply internationally recognized GxP standards
- Reference PIC/S guidance where relevant
- Review quality systems and documentation
- Evaluate computerized systems and data integrity
- Review validation and engineering controls such as HVAC and cleanrooms
Reporting & Regulatory Action
- Prepare clear and structured inspection reports
- Identify and describe compliance gaps precisely
- Review corrective-action plans submitted by companies
- Recommend appropriate regulatory actions
- Communicate findings to stakeholders professionally
- Track follow-up items until they are closed
Procedures, Guidance & Capability Building
- Support development of inspection procedures
- Contribute to technical guidance documents
- Share inspection expertise with colleagues
- Help build inspector capability across the team
- Review and refine inspection methods over time
- Support training on GxP inspection practice
Qualifications & Requirements
Education
- Bachelor’s or Master’s degree in Pharmacy or Pharmaceutical Sciences
- Degree in Biotechnology, Biomedical Engineering, or Chemical/Pharmaceutical Engineering
- Degree in IT or Software Engineering
- Other related disciplines considered
Experience
- Strong relevant experience in pharmaceutical or biologics environments
- Experience in ATMP, sterile-product, or clinical-research settings
- Experience in medical-device or regulatory inspection environments
- Demonstrated inspection, auditing, or manufacturing experience
Technical Knowledge
- Practical knowledge of GMP
- Practical knowledge of GDP
- Practical knowledge of GCP
- Practical knowledge of GAMP 5 and other GxP standards
Certifications
- Formal auditor or inspector certification (preferred)
- GCP auditor certification (required for the GCP specialism)
- Exposure to PIC/S inspection principles and requirements (strongly preferred)
Communication & Language
- Excellent report-writing skills
- Strong stakeholder-management skills
- Professional English communication
- Arabic language skills (advantage)
Career Development & Growth Opportunities
Professional Advancement
- Pathway toward Lead Inspector or Head of Inspection roles
- Opportunity to specialize in biologics, sterile, or GCP inspection
- Influence on national inspection procedures and guidance
- Growth within a major UAE regulatory authority
Learning & Development
- Exposure to PIC/S inspection principles and practice
- Advanced training in GxP and computerized systems
- Development of inspection leadership and report-writing skills
- Experience with regulatory decision-making at national level
About Emirates Drug Establishment — Protecting Public Health
Emirates Drug Establishment is the UAE’s regulator for licensing and controlling pharmaceutical and medical products. Its inspection teams assess manufacturers, facilities, and operations against UAE requirements and internationally recognized standards, supporting safe access to medicines and health products for the public. The organization is building its good practices inspection capability to meet the growing complexity of biologics, advanced therapies, sterile manufacturing, and medical devices.
Career Excellence in Pharmaceutical Regulation: Join a national regulator in Dubai, conduct risk-based GxP inspections, apply GMP, GCP, and GAMP 5 expertise to real operations, shape inspection procedures and guidance, and build a senior career in pharmaceutical quality and regulation in the UAE.
Who Should Apply?
- Pharmaceutical Quality Professionals: With inspection experience
- GMP Auditors: Seeking a regulatory career
- GCP Auditors: With recognized certification
- Validation and Computerized Systems Specialists: With GAMP 5 expertise
- Biologics and ATMP Experts: Ready for a regulatory role
- Pharmaceutical Engineers: Moving into regulatory inspection
