Specialist Quality Assurance - Global Supply Quality

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.

In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with suppliers of raw materials and devices. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. You will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of external suppliers and contract manufacturers including raw materials, packaging components, and medical devices.

• Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type.
• Documentation review and approval including: supplier records, investigation reports, Amgen quality records, and validation records.
• Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles
• Oversight and completion of supplier assessments and documentation to support product complaints.
• Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.
• Review and approval of change control records for supplier changes.
• Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence.
• 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.
• Take part in operational and quality improvement initiatives, programs, and projects.
• Develop solutions that are thorough, practical, and consistent with functional objectives

• Doctorate degree OR
• Master’s degree with 4 to 6 years of experience in quality management systems or a related field OR
• Bachelor’s degree with 6 to 8 years of experience in quality management systems or a related field OR
• Diploma with 8+ years of experience in quality management systems or a related field.

• Minimum of 2 years working in a cGMP manufacturing environment with a demonstrable understanding of regulatory requirements and expectations.

• Experience in investigations, project management and trending and analysis
• Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
• Desire to partner with internal and external collaborators across teams
• Understanding of industry requirements/expectations of a robust Quality Management System and documentation.

• Excellent analytical and troubleshooting skills.
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills

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.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.