R&D Supplier Quality Senior Manager

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

R&D Supplier Quality Senior Manager

What you will do

Let’s do this. Let’s change the world. R&D Quality is developing a Supplier Quality Oversight capability with the primary objective of delivering a robust, risk-based supplier quality program capable of identifying key leading indicators which will predict and prevent critical quality issues.

This role as R&D Supplier Quality Senior Manager will report to the Director, R&D Supplier Quality Management in Precision Medicine, Diagnostics and Supplier Quality (PMDSQ) and will be responsible for the Quality oversight of GCP, GLP and GPvP regulated suppliers and service providers used in the R&D organization. This role requires a dedicated professional with a passion for quality management and the ability to identify and execute process improvements, ensuring the highest operational standards.

The role involves establishing and cultivating robust, quality-focused relationships with Amgen suppliers, providing risk-based quality supervision during supplier evaluation and selection, managing supplier-related quality records efficiently and compliantly, and ensuring prompt escalation of high-risk issues to leadership.

Furthermore, candidates should be, along with the ability to employ or implement various tools to support supplier quality processes.

Key Areas of Responsibility:

• Quality-oversee supplier management, ensuring compliance with industry standards and best practices

• Participate in negotiations of contractual agreements with suppliers and build strong long-term relationship with their quality organizations

• Operate efficiently within a global, matrixed organization, coordinating effectively across multiple time zones

• Collaborate with research and other functions to drive the implementation of continuous improvement initiatives.

• Function as the quality lead for the execution of quality records related to R&D Supplier management activities

• Define and maintain R&D Supplier Quality KPI/Metrics to ensure timely and appropriate response to key quality signals

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Quality Management or other relevant experience OR

• Master’s degree and 4 years of Quality Management or other relevant experience OR

• Bachelor’s degree and 6 years of Quality Management or other relevant experience OR

• Associate’s degree and 10 years of Quality Management or other relevant experience OR

• High school diploma / GED and 12 years of Quality Management or other relevant experience

Preferred Qualifications:

• Experience in supplier quality management or oversight

• Working knowledge of GCP, GLP and GPvP regulations, practices, and trends

• Excellent project management abilities

• Experience working in a global, matrix organization across multiple time zones

• Experience in contract negotiations and relationship building with suppliers

• Experience in transactional lean, value stream mapping, and identifying areas of process design and improvement

• Ability to adapt to changing business needs

• Effective and timely decision making and influencing skills executed in a timely manner

• Strong leadership, negotiation, critical thinking and analytical skills

• Skilled in both written and verbal communication for engaging with individuals at all levels within the organization.

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