Quality Director

2 weken geleden


Amsterdam, Nederland EVA pharma Voltijd

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 requires frequent travel to oversee operations at 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 #J-18808-Ljbffr


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