Marketing Company Operations Quality Senior Specialist

Responsibilities

• Oversee the design, implementation, and delivery of a common Quality system for all local GMP and GDP activities in Egypt
• Serve as the primary GMP/GDP contact for the country and provide leadership to the Senior Executive Team
• Execute country quality plans to enable market expansion and product launches
• Define, develop, and monitor GMP/GDP policies and standards to ensure compliance with worldwide requirements
• Lead the Country Quality Management Review process, including escalation and follow-up
• Drive global standardization and simplification of Affiliate Quality business processes
• Provide training, support, and coaching for the regional Quality affiliate network
• Manage the country Quality organization budget
• Ensure adherence to GMP, GDP, GLP, Quality, Health, and Safety regulatory requirements
• Manage country-specific requirements for manufacture and distribution, including batch release and recall management
• Conduct compliance reviews for external suppliers and lead issue management teams
• Identify and escalate risks to Regional Quality and implement improvement plans

Requirements

• Experience in quality assurance within a pharmaceutical marketing company or distribution environment
• Experience in GMP and GDP country-level roles
• Excellent communication and organizational skills
• Strong business acumen with high ethical standards
• Ability to balance technical quality requirements with industry standards to achieve business goals
• Experience reviewing GMP and GDP specific quality management data for trends
• Ability to develop capability plans for local GMP and GDP compliance

Preferred Qualifications

• Post-graduate qualification
• Operational expertise in Quality management

About the Company

AstraZeneca is a global, science-led BioPharmaceutical company that aims to deliver life-changing medicines to patients through innovation and collaboration.