🌟 Join Amgen's Mission to Transform Lives! 🌟
At Amgen, you’re not just taking on a job—you’re becoming part of a bigger mission: improving the lives of patients battling serious illnesses.
Since 1980, Amgen has been at the forefront of biotech innovation, tackling some of the world’s most challenging diseases. Focused on Oncology, Inflammation, General Medicine, and Rare Diseases, we positively impact millions of lives each year. As part of our dynamic team, you’ll play a vital role in researching, developing, and delivering cutting-edge medicines that help people live longer, healthier, and happier lives.
Our culture is award-winning, collaborative, and driven by science. If you thrive on challenges and love solving complex problems, Amgen is the place for you. Join us in transforming the future of healthcare—and your career!
📈 Specialist Quality Assurance - Global Supply Quality 📈
Your Role in Making a Difference
Are you ready to change the world? In this crucial role, you’ll collaborate with Amgen’s global quality teams, manufacturing sites, and suppliers to ensure the highest standards in raw materials and devices. Your work will help build a resilient supply network, ensuring patients receive the best possible treatments.
As a part of the Global Supply Quality Team, you’ll oversee and maintain relationships with external suppliers and contract manufacturers, playing a pivotal role in ensuring product excellence.
Key Responsibilities:
✅ Maintain and update quality agreements to align with Amgen’s standards. ✅ Review and approve critical documentation, including supplier records and validation reports. ✅ Evaluate and document changes in raw materials and device inspection profiles. ✅ Oversee supplier assessments and support product complaint resolutions. ✅ Manage supplier performance metrics and key documentation to ensure quality partnerships. ✅ Review and approve supplier change control records. ✅ Oversee supplier audits, ensuring timely completion and compliance with CAPA closeout activities. ✅ Develop, review, and approve SOPs and GMP/GDP documentation in line with corporate and regulatory requirements. ✅ Participate in quality improvement initiatives and operational projects. ✅ Develop practical, innovative solutions that align with functional objectives.
🌐 This role may require working in shifts or extended hours to support global operations.
What We’re Looking For:
We celebrate diversity and unique contributions! Here’s what we expect:
Basic Qualifications:
🎓 Doctorate degree OR
🎓 Master’s degree with 4+ years of experience in quality management OR
🎓 Bachelor’s degree with 6+ years of experience in quality management OR
🎓 Diploma with 8+ years of experience in quality management.
Preferred Qualifications:
✅ Must-Have Skills:
✔️ Minimum 2 years of experience in a cGMP manufacturing environment with knowledge of regulatory requirements.
✅ Good-to-Have Skills:
✔️ Experience in digital solutions and computerized systems.
✔️ Strong background in investigations, project management, and data analysis.
✔️ Familiarity with Supplier Management, raw materials, packaging, and device manufacturing.
✔️ Knowledge of API, Drug Substance, Drug Product, Packaging, and combination product regulations.
✔️ Ability to collaborate with internal and external stakeholders.
✔️ Understanding of Quality Management Systems and regulatory expectations.
✅ Soft Skills:
✔️ Strong analytical and troubleshooting abilities.
✔️ Excellent verbal and written communication skills.
✔️ Ability to work effectively in a global, virtual team.
✔️ Self-motivated with a proactive approach.
✔️ Ability to manage multiple priorities efficiently.
✔️ Team-oriented mindset focused on achieving shared goals.
✔️ Confident presenter with strong public speaking skills.
🌟 What You Can Expect From Us 🌟
At Amgen, we’re committed to your growth and well-being just as much as we’re committed to advancing medicine. From competitive benefits to a collaborative work culture, we support you every step of the way.
Along with a competitive salary, Amgen provides comprehensive Total Rewards Plans aligned with industry standards.
Apply from here