Quality Manager| ELI

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Quality Manager

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)

Qualifications

• About the job

  HOW MIGHT YOU DEFY IMAGINATION?

  If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
  
  Quality Manager

  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)

• Qualifications

• Fluent in both Arabic and English languages
• Bachelor’s degree or equivalent in Pharmacy or Life Sciences
• Typically, +8 years of related professional experience in quality assurance
• Current or previous experience within a MNC
• Strong word processing, database and spreadsheet application skills
• Hands-on experience in implementing Quality Management Systems
• Strong communication skills and cross-functional collaboration

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.

Qualifications:

• Bachelor’s degree (or equivalent) in Pharmacy or Life Sciences.
• Minimum 5+ years of relevant professional experience in Quality Assurance, GMP, and GDP environments.
• Fluency in Arabic and English languages.

Behavioral Competencies:

• Strong communication and collaboration skills.
• Ability to synthesize information and make informed decisions.
• Task-oriented with a focus on timely, high-quality deliverables.

Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.