Quality Manager ELI

Amgen

What You Will Do

• The Quality Manager is required to participate as a core team member in the International Expansion product/country launch teams and product licensing efforts assisting in the liaison activities between Quality and all other key stakeholders and/or partner companies
• Collaborate with Regulatory in the identification of specific requirements for new product introduction
• Perform technical assessments/ audits of partner warehouses
• Negotiate and facilitate the development of Quality Agreements
• Develop, and maintain the required quality systems necessary for the effective management of business relationship in compliance with Amgen and regulatory requirements.
• Provide oversight for all aspects related to in-country product distribution and storage
• Participate in the development of new product/country strategic plans and participate in the execution of applicable tasks to successfully accomplish project goals
• Develop reports and provide the necessary communications throughout the organizations as required to ensure effective information sharing
• Represent Amgen in all matters related to Health Authorities and any other governmental agencies handling quality matters
• Understand the regulations in relation to Distribution in Middle east countries, the European Pharmaceutical Directive related to Distribution of Medicinal Products and full understanding of Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP)

Required Knowledge & Skills:

Regulatory Expertise

• Regional regulations for distribution of medicinal products
• Principles and guidelines of GMP and GDP
• Awareness of Falsified Medicines Directive, European Medicines Agency (EMA)

Technical Competencies

• Strong understanding of Quality Assurance principles.
• Proficiency in Digitalization and related applications.
• Familiarity with Information and Communication Technologies.