External Supply RMD QRO Specialist

About this role

Career Category Manufacturing Job Description 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

External Supply RMD QRO Specialist

What you will do Let’s do this. Let’s change the world. In this vital role you will play a vital role in supporting the Amgen manufacturing network.  Our work includes 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 QRO Specialist 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. This Specialist Manufacturing will act as the External Supply QRO representative across functional teams and external suppliers to drive closure of quality records in a timely manner. The Specialist Manufacturing External Supply owns and manages quality records originating from manufacturing sites across the global Amgen network. • 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.

What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries experience OR Bachelor’s degree and 4 years of Quality and/or Manufacturing in the pharmaceutical, biotech or medical device experience OR Associate’s degree and 8 years of Quality and/or Manufacturing in the pharmaceutical, biotech or medical device experience OR High school diploma / GED and 10 years Quality and/or Manufacturing in the pharmaceutical, biotech or medical device 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 in devices and primary and secondary packaging materials

• 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

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