Senior Associate Quality Assurance - Global Supply Quality

Lets do this. Lets 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

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

Basic Qualifications:

• Masters degree and 1 to 3 years of professional experience in related fields OR
• Bachelors 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