Senior Manager, In-Vitro Diagnostics, Precision Medicine Quality

🕒 Outubro 8

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $132.037 - $178.638 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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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 quality oversight of IVD medical devices used within Amgen’s precision medicine and digital medicine clinical trials • Provide subject matter expertise on regulatory and quality oversight of IVDs, including CDx, LDTs and assays • Support clinical trial inspections from health authorities, including inspection readiness and management of findings • Collaborate with IVD and diagnostic partners to ensure quality oversight and regulatory compliance • Advance IVD/CDx quality management strategies in response to the evolving EU and US regulatory landscape • Support Quality Agreements, clinical trial protocol reviews, informed consent form reviews and IRB application reviews • Support EU Clinical Performance Studies and US IDE requirement implementation • Contribute to collection and use of KQI/KPI metrics for Quality Management System performance and improvement • Maintain current knowledge of IVD regulations and guidance; monitor regulatory developments and communicate business impact • Provide risk-based quality assurance and oversight, including auditing, deviation management and inspection management • Ensure integrated procedures are fit for purpose and aligned with Amgen standards • Report to the Director of Precision Medicine and Diagnostics Quality within R&D Quality

🎯 Requisitos

• Doctorate degree and 2 years of quality, regulatory or Companion Diagnostic experience OR Master’s degree and 4 years of quality, regulatory, or Companion Diagnostic experience OR Bachelor’s degree and 6 years of quality, regulatory, or Companion Diagnostic experience OR Associate’s degree and 10 years of quality, regulatory, or Companion Diagnostic experience OR High school diploma / GED and 12 years of quality, regulatory, or Companion Diagnostic experience • Experience within the pharmaceutical/ biotech, medical device, and/or biomarker industry working with In-Vitro Diagnostics (IVD) and preferably Companion Diagnostic (CDx) devices • Experience at EU clinical trial sites, either as a site monitor or study management • Experience working with Companion Diagnostics/assay development for the pharmaceutical industry/CLIA cert and/or ISO 15189 cert labs/biomarker testing • Experience working in a quality management system role or relevant clinical research environment with quality oversight • Working knowledge of IVD medical device development, including design controls • Knowledge of global regulations related to companion diagnostics and assay development, including EU IVDR and FDA CDx Final Rule • Understanding of Precision Medicine and applicable global regulations • Understanding of EU IVD performance studies under EU IVD Regulation • Understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise • Experience with GxP requirements and oversight of third-party vendors, suppliers, and partners • Ability to incorporate feedback into clear, efficient processes • Strong analytical, critical-thinking, and decision-making abilities • Experience developing and implementing analytics methods and technology for signal detection and quality improvement • Innovative thinking, including application of quality by design principles • Ability to work collaboratively and support a high-performing team

🏖️ Benefícios

• Comprehensive employee benefits package • 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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