Specialist Manufacturing - External Supply

What you will do

In this vital role you will be managing supplier notifications and investigations related to raw material and device defects, onboarding new or alternate raw materials, suppliers, sites, and managing life-cycle changes to existing materials or suppliers.

The External Supply Specialist Manufacturing is expected to own and execute independently all the processes related to Raw Material and Devices (RMD) quality records, including Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations (minor and major), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications.

• Own, manage, and close quality records (Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations, Corrective and Preventive Actions (CAPAs), and CAPA-Effectiveness Verifications) under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
• Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance or timely implementation of supplier/raw material related changes.
• Partner cross-functionally across the network to ensure maturity and execution of robust quality record process.
• Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)
• Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV).
• Collaborate closely with External Supply Quality, ES SRE teams, Amgen sites, and suppliers to ensure robust supplier/raw material investigations, timely change implementation, and compliance with KPI metrics.
• Build and present quality record summaries for Senior Management review.
• Provide timely and comprehensive process and status updates to senior management in multiple forums and keeping tracking tools updated.

Basic Qualifications

• Doctorate degree OR
• Master's degree and 2 years of Manufacturing experience OR
• Bachelor's degree and 4 years of Manufacturing experience OR
• Associate's degree and 8 years of Manufacturing experience OR
• High school diploma / GED and 10 years of Manufacturing experience

Preferred Qualifications

• 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Experience managing quality records (EN/SICAR, Change Controls, Deviations, CAPAs, CAPA-EV) using TrackWise or Veeva System
• Demonstrated proficiency in managing change controls in alignment with quality system requirements, regulatory expectations, and business timelines
• Project Management and/or Quality Management skills and experience.
• Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Experience presenting to and interacting with representatives of regulatory agencies.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Demonstrated ability to lead continuous improvement opportunities and complex cross-functional initiatives that enhance processes, improve operational efficiency, and support timely, compliant execution across internal teams and Amgen sites.
• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
• Experience navigating and executing transactions in SAP (ERP) or S4HANA system.
• Experience applying AI-enabled tools in a regulated environment.
• Experience contributing to the design, development, or implementation of AI-enabled tools as part of process improvement initiatives or projects.
• Ability to translate business or quality process needs into practical solutions and evaluate outputs for accuracy, data integrity, and compliance with applicable requirements
• Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met.
• Ability to tactfully negotiate and positively influence peers and executive leadership.
• Demonstrated ability to deliver results through living the Amgen values.
• Strong negotiation skills when working with external suppliers and internal team members.
• Ability to maintain remote working relationships with colleagues at other Amgen sites.