R&D Supplier Quality Manager

🕒 Outubro 9

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $104.287 - $141.094 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 7%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 33 dias.
• As vagas desta empresa costumam ser preenchidas em 21 dias.

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Support qualification, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline • Execute supplier quality management processes for R&D suppliers under GCP, GLP, and GPvP regulations • Oversee suppliers providing, hosting, developing, validating, maintaining, or supporting GxP computerized systems • Conduct risk-based supplier assessments, qualification, audits, and lifecycle management, including quality agreements • Lead or support qualification and ongoing oversight of suppliers using or providing GxP computerized systems, interfaces, and devices • Assess and oversee supplier AI-enabled GxP computerized systems for compliance with procedural controls, policies, and standards • Plan, lead, and document risk-based audits of supplier GxP computerized systems and quality processes • Assess supplier controls for validation, data integrity, security, access management, change and configuration management, incidents, backup, recovery, business continuity, and decommissioning • Review quality and technical requirements in supplier contracts and quality agreements • Participate in supplier governance and periodic reviews; evaluate performance, validation status, changes, deviations, incidents, audit outcomes, emerging risks, and CAPA effectiveness • Support inspection readiness and regulatory responses related to supplier computerized systems • Monitor supplier performance, track KPIs, and escalate quality issues • Coordinate and/or execute supplier audits, manage findings, initiate quality records, and ensure timely CAPA closure • Maintain supplier data in quality systems such as Veeva and TrackWise • Engage suppliers on requirements, governance, and process improvement initiatives • Ensure procedural compliance, perform quality checks, and contribute to continuous improvement • Collaborate with R&D, Supply Chain, Sourcing, and QA teams on supplier quality strategies

🎯 Requisitos

• Doctorate degree OR Master’s degree and 2 years of Science, Engineering, or experience in a related field OR Bachelor’s degree and 4 years of Science, Engineering, or experience in a related field OR Associate’s degree and 8 years of Science, Engineering, or experience in a related field OR High school diploma / GED and 10 years of Science, Engineering, or experience in a related field • Knowledge of GxP, ISO standards, and regulatory expectations for R&D suppliers • Experience with supplier quality risk assessment tools and audit practices • Working knowledge of computerized system validation and assurance principles • Knowledge of risk-based system lifecycle practices and expectations for electronic records, electronic signatures, audit trails, and data integrity • Experience assessing or overseeing GxP technology suppliers, including software, software-as-a-service, cloud, hosting, infrastructure, implementation, validation, and managed service providers • Ability to evaluate supplier audit reports, validation plans and reports, requirements and traceability, testing evidence, security and continuity controls, change records, deviations, CAPAs, and service performance data • Experience and proficiency in overseeing AI-enabled GxP systems, including risk assessment, governance, validation, data integrity, and ongoing supplier monitoring • Excellent written and verbal communication skills • Ability to work effectively in cross-functional teams and in a matrixed environment • Strong problem-solving and critical thinking abilities • Detail-oriented with a continuous improvement mindset • Proactive collaboration and relationship-building skills • Ability to manage multiple priorities and deliver results under timelines • Sponsorship for this role is not guaranteed

🏖️ Benefícios

• Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support • Up to 10% domestic and international travel may be required for supplier engagements and audits

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