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)
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
Required Knowledge & Skills:
Regulatory Expertise
Technical Competencies
Qualifications:
Behavioral Competencies:
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.
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.