Sr Associate Supplier Quality

 

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.

  
 

Sr Associate Supplier Quality 
  
 

What you will do 


The Sr Associate Supplier Quality position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen multi-functional raw materials suppliers’ team that includes but is not limited to business operations, analytical science, process development, and supply chain.

  
 

Role Description 
Working independently, the individual will be responsible for, but not limited to the following:

Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation

Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP

Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations

Collaborate with raw material suppliers to ensure alignment to quality agreements, identifying performance improvement opportunities

Understand and incorporate risk management strategy into the overall raw material lifecycle

Provide support to the supplier periodic monitoring oversight activities

Support in tactical activities related to internal/external audits and inspections

Perform routine quality assessments and provide approval of changes to raw material inspection profiles

Take part in operational improvement initiatives, programs, and projects

Develop solutions that are thorough, practical, and consistent with functional objectives

Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships

Work under minimal supervision in line with Amgen Values and Leadership Attributes

  
 

What we expect of you 
  
 

Education and Experiences: 

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:

Bachelor’s degree in science or engineering and 2+ years of professional experience in related fields

Understanding of GMP/GDP requirements

Familiarity with raw material compendial testing

Experience overseeing quality of suppliers or external parties

Deep technical writing skills

  
 

Preferred Qualifications 

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 visualizing

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

Ability to communicate across all levels of the organization

Effective written and verbal communication skills

Experience with Microsoft Office Tools including Excel, Word, and PowerPoint

Ability to multi-task and prioritize

  
 

What you can expect of us 
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.