Senior Associate Quality Assurance - Global Supply 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.

Senior Associate Quality Assurance - Global Supply Quality

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the Quality and Compliance Oversight of suppliers a services providers vendor master data for all operations. As an integral member of Amgen Global Supply Quality team, you will also ensure additional Quality System and business tool needs are met for the organization.

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

• Perform Own transactional activities related to raw material and vendor master data in the enterprise resource planning system, own transactional activities associated with other Global Supply Quality tasks (ex. Audit Management System (AMS), Supplier Change Notification (SCN) Mailbox and records, training support, etc.)

• Work closely with all relevant key collaborators 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 internal key collaborators, identifying performance improvement opportunities maximizing digital tools and AI for efficiencies

• Understand and incorporate risk management strategy into the overall suppliers and service providers 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 assessments of changes that impact master data.

• Take part in operational improvement initiatives, programs, and projects

• Develop solutions that are detailed, practical, and consistent with functional objectives

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

• Work under minimal direction in line with Amgen Values and Leadership Attributes

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Master’s degree and 1 to 3 years of professional experience in related fields OR

• Bachelor’s degree and 3 to 5 years of professional experience in related fields OR

• Diploma and 7 to 9 years of professional experience in related fields

• Understanding of GMP/GDP requirements.

• Strong technical writing skills.

Preferred Qualifications:

• Experience with ERP (ex SAP) Systems and Vendor Master Data

• Strong continuous improvement attitude 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

• Familiarity with requirements of managing suppliers and service providers

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.

Apply now for a career that defies imagination

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

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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.