Quality Compliance Manager – Europe Cluster

🔥 2 minutes ago

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EVA pharma

1001 - 5000 employees

Founded 1997

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

EVA Pharma is a leading Egyptian pharmaceutical company with a century-long heritage that researches, develops and manufactures a broad portfolio of medicines and biologics. The company operates three internationally accredited manufacturing facilities, two research centers, and a global footprint with multiple legal entities, producing more than a million packs per day and focusing on therapeutic areas such as oncology, neuroscience, respiratory, cardiometabolic, anti-infectives, ophthalmology, bone health, hepatology and reproductive health. EVA Pharma partners with international biopharma firms, pursues tech-transfer and local manufacturing of complex biologics to increase access in low- and middle-income countries, and maintains a large pipeline of products alongside active licensing and collaboration efforts.

📋 Description

• Maintain and continuously improve the local Quality Management System (QMS). • Manage quality documentation, including SOPs, forms, records, and periodic reviews. • Coordinate employee training, qualification programs, and compliance records. • Lead supplier, customer, and service provider qualification activities. • Plan, conduct, and follow up on internal audits and quality assessments. • Manage deviations, quality events, CAPAs, and process improvement initiatives. • Oversee quality-related interfaces with manufacturers, external service providers, and batch release partners. • Prepare for, coordinate, and support regulatory authority inspections while ensuring ongoing inspection readiness.

🎯 Requirements

• Degree in Pharmacy, Life Sciences, or a related scientific discipline. • Minimum 5-7 years of experience in pharmaceutical or healthcare quality management systems. • Experience as a Responsible Person for Wholesale Distribution under German Medicines Act (AMG §52a). • Strong knowledge of GxP requirements, German pharmaceutical regulations, and EU compliance standards. • Manage multiple quality activities, and effectively interact with internal and external stakeholders.

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