Senior Manager, In-Vitro Diagnostics, Precision Medicine Quality

🕒 il y a 18 jours

🇺🇸 États-Unis – Télétravail

💵 $132 037 - $178 638 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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