Quality Director

Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.

Role Overview
As a Quality Director, you will be responsible for providing strategic direction and leadership to our entire Quality function. Reporting directly to the CEO, you will develop and execute a robust quality strategy, ensure unwavering compliance with international regulatory standards, and foster a culture of continuous improvement and operational excellence across all our manufacturing sites and external partners.

Key Responsibilities

Quality Strategy & Compliance
• Define and execute a quality strategy aligned with global standards (cGMP, FDA, EMA, WHO, SFDA).
• Ensure full compliance across all manufacturing sites, CMOs, and API suppliers.

Operational Quality Oversight
• Lead QA, QC, and Microbiology to ensure efficient batch release and reliable market supply.
• Oversee accurate testing, batch release, and stability programs.

Regulatory Inspections & Audits
• Manage preparation and response for regulatory inspections (FDA, EU QP, WHO, etc.).
• Liaise with regulatory agencies during inspections and audits, ensuring prompt, transparent, and compliant responses to findings)

·       Act as the subject matter expert (SME) for quality audits, inspections, and certifications

Risk Management & Improvement
• Lead risk identification, mitigation, and quality improvement initiatives.

 Cross-functional Collaboration:

·       Collaborate with senior leadership and other departments, including R&D, regulatory affairs and operations to resolve quality issues and develop innovative solutions.

·       Support product development teams to ensure quality is embedded into new product development from the outset.

Requirements

• Education: Bachelor’s in pharmacy (mandatory); master’s or certification in Quality Management (preferred).
• Experience: 20+ years in pharmaceutical QA/QC, with 10+ years in senior leadership.
• Expertise in global cGMP, QMS, and regulatory compliance (FDA, EMA, SFDA, WHO).
• The Role rquires frequent Travel overseeing Operations at our sites in Cairo & KSA
• Proven track record in branded generics and international regulatory frameworks.
• Solid performance in driving quality improvements and managing cross-functional teams.
• Strong  expertise in  quality management systems, risk management, CAPA, and root cause analysis