Senior R&D Supplier Quality Manager

🕒 Outubro 9

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $132.037 - $178.638 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 7%

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• 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

• Provide risk-based Quality governance and oversight for R&D suppliers • Support and facilitate a cross-functional R&D and Operations forum for clinical quality issues • Coordinate intake and risk-based triage of complex clinical supplier and Quality issues • Identify applicable requirements, potential Quality and business risks, subject matter experts, and accountable functions • Partner with Quality and business stakeholders to establish supplier qualification and oversight strategies • Support development, negotiation, and maintenance of Quality Agreements and supplier Quality requirements • Collaborate with research and other functions on continuous improvement initiatives • Act as Quality lead for quality records related to R&D Supplier management • Define and maintain R&D Supplier Quality KPIs and metrics • Drive escalation, documentation, and continuous improvement for supplier-quality risks • Coordinate across multiple functions and time zones in a global, matrixed organization

🎯 Requisitos

• Doctorate degree and 2 years of Quality Management or other relevant experience OR Master’s degree and 4 years OR Bachelor’s degree and 6 years OR Associate’s degree and 10 years OR high school diploma/GED and 12 years • Experience in supplier quality management or oversight • Working knowledge of GCP, GLP, GPvP, GMP, and GDP regulations, practices, and trends • Experience in clinical supply chain Quality or oversight of GMP/GDP-regulated services used in clinical development • Practical experience applying GMP and/or GDP requirements within a regulated life sciences environment • Ability to influence and drive progress across functions • Effective decision-making and influencing skills • Strong leadership, negotiation, critical thinking, and analytical skills • Written and verbal communication skills • Ability to use tools and systems supporting supplier quality management processes • Excellent project management abilities • Experience in a global, matrix organization across multiple time zones • Experience supporting supplier quality oversight across complex, cross-functional, or global environments • Experience in contract negotiations and supplier/service-provider relationship building • Experience in transactional lean and value stream mapping • Ability to adapt to changing business needs and navigate ambiguity • Willingness and capability to travel up to 15% • Sponsorship is not guaranteed

🏖️ Benefícios

• Health and welfare plans for staff and eligible dependents • 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 • Financial plans with opportunities to save towards retirement or other goals • Work/life balance

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