Quality Director
- الجيزة
- دائم
- دوام كامل
As a Quality Director, youKey ResponsibilitiesQuality 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.
- Lead QA, QC, and Microbiology to ensure efficient batch release and reliable market supply.
- Oversee accurate testing, batch release, and stability programs.
- 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)
- Lead risk identification, mitigation, and quality improvement initiatives.
- 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).
- 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