External Supply RMD QRO Specialist

Amgen

Specialist Manufacturing managing quality records for raw materials and devices at Amgen. Collaborating with suppliers and ensuring compliance with quality regulations while resolving issues.

Posted 7/30/2026full-timeThousand Oaks • California, North Carolina, Ohio, Rhode Island • 🇺🇸 United StatesMid-LevelSenior💰 $107,545 - $145,502 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing quality records, including Supplier Event Notifications, Change Controls, and CAPAs, while ensuring compliance with regulatory requirements. Proven ability to lead cross-functional teams and drive process improvements in the pharmaceutical, biotech, or medical device industries.

Highest-signal resume keywords

Quality Record ManagementChange Control ManagementProject Management SkillsRegulatory Compliance ExperienceCross-Functional Team Leadership

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Supplier Event NotificationsChange ControlsDeviationsCorrective and Preventive Actions (CAPAs)TrackWiseVeeva SystemCausal Factor AnalysisFault Tree AnalysisKepner-TregoeSAP (ERP) or S4HANA

Soft Skills

Excellent Communication SkillsInterpersonal SkillsNegotiation SkillsProblem SolvingFacilitation Skills

Tools & Technologies

Microsoft Office ToolsTrackWiseVeeva SystemSAP (ERP)S4HANA

Industry Keywords

Pharmaceutical IndustryBiotech IndustryMedical Device IndustryQuality Management SystemRegulatory Agency Interaction

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

The External Supply (ES) Raw Material and Devices Quality Records (RMD QRO) global team plays 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 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.
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.
Responsibilities include, but are not limited to the following: 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.

Requirements

What you’ll need

Doctorate degree OR Master’s degree and 2 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries OR Bachelor’s degree and 4 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries OR Associate’s degree and 8 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries OR High school diploma/GED and 10 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries.
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.
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.

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.