Senior Associate Supplier Quality Professional – Quality and Compliance Oversight of Raw Material Suppliers in the Biotechnology Industry

Introduction to Amgen and Our Mission

At Amgen, we're driven by a shared mission to serve patients living with serious illnesses. As a pioneer in the biotechnology industry since 1980, we've been at the forefront of developing innovative medicines to help people live longer, fuller, and happier lives. Our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – enables us to reach millions of patients each year. We're committed to unlocking the potential of biology to improve health outcomes and dramatically improve people's lives. If you're passionate about making a difference in the lives of patients and are looking for a challenging and rewarding career, we invite you to join our team as a Senior Associate Supplier Quality Professional.

Job Overview

The Senior Associate Supplier Quality position is a critical role within our organization, responsible for the quality and compliance oversight of raw material suppliers. As a key member of our multi-functional raw materials suppliers' team, you'll work closely with stakeholders from business operations, analytical science, process development, and supply chain to ensure compliance with GMP/GDP regulations and corporate requirements. Your expertise will be essential in driving success and ensuring the quality of our raw materials.

Key Responsibilities

• Perform QA Contact role on Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification, and documentation
• Collaborate with stakeholders to ensure end-to-end process compliance with GMP/GDP regulations
• Prepare, review, and approve SOPs and other GMP/GDP documentation to ensure alignment with procedures and regulatory requirements
• Work with raw material suppliers to ensure alignment with quality agreements and identify performance improvement opportunities
• Develop and incorporate risk management strategies into the overall raw material lifecycle
• Support supplier periodic monitoring oversight activities and tactical activities related to internal/external audits and inspections
• Perform routine quality assessments and provide approval of changes to raw material inspection profiles
• Participate in operational improvement initiatives, programs, and projects to develop solutions that are thorough, practical, and consistent with functional objectives
• Own supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships

Essential Qualifications

To be successful in this role, you'll need:

• A Bachelor's degree in science or engineering and 2+ years of professional experience in related fields
• Understanding of GMP/GDP requirements and familiarity with raw material compendial testing
• Experience overseeing quality of suppliers or external parties
• Deep technical writing skills

Preferred Qualifications

While not required, the following qualifications are preferred:

• Strong continuous improvement approach and lean practices experience
• Understanding of end-to-end supply chain business processes
• Experience in project management across multiple departments and geographies
• Quick process understanding, insight, and visualization
• Strong analytical and problem-solving skills
• Independent self-starter, able to work autonomously, under pressure, and in teams
• GMP/GDP knowledge and understanding of pharmaceutical regulations
• Energetic, detail-oriented, highly motivated with a "can-do" outlook
• Change management skills
• Effective written and verbal communication skills
• Experience with Microsoft Office Tools, including Excel, Word, and PowerPoint
• Ability to multi-task and prioritize

Career Growth Opportunities and Learning Benefits

At Amgen, we're committed to supporting your professional and personal growth and well-being. As a Senior Associate Supplier Quality Professional, you'll have access to:

• Competitive benefits and comprehensive Total Rewards Plans
• Opportunities for career advancement and professional development
• A collaborative and inclusive work environment
• Training and development programs to enhance your skills and knowledge
• A culture that values innovation, science, and patient-centricity

Work Environment and Company Culture

Our award-winning culture is built on a foundation of collaboration, innovation, and science. We're a team of diverse, ethical, committed, and highly accomplished individuals who respect each other and live the Amgen values. As a member of our team, you'll be part of a dynamic and supportive work environment that encourages open communication, creativity, and innovation.

Compensation, Perks, and Benefits

We offer a competitive salary and comprehensive benefits package, including:

• Base salary
• Comprehensive Total Rewards Plans
• Opportunities for career advancement and professional development
• A collaborative and inclusive work environment
• Training and development programs
• A culture that values innovation, science, and patient-centricity

Conclusion

If you're a motivated and experienced quality professional looking for a challenging and rewarding career, we invite you to apply for the Senior Associate Supplier Quality position. As a member of our team, you'll play a critical role in ensuring the quality and compliance of our raw materials and contributing to the development of innovative medicines that improve the lives of patients. Apply now and join our mission to serve patients and transform the lives of those living with serious illnesses.