Senior Advisor – CSQA Representative, Catalyze360 Quality

🔥 15 horas atrás

🏄 California, North Carolina, +1 estados a mais – Remoto

🏄 California – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote

💵 $129.000 - $211.200 / ano

⏰ Tempo Integral

🟠 Sênior

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Eli Lilly and Company

SiteLinkedInTodas as Vagas

10.000+ funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

💰 $6.500.000 Post-IPO Debt - Eli Lilly em 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company é uma empresa farmacêutica multinacional que pesquisa, desenvolve, fabrica e comercializa medicamentos de prescrição em várias áreas terapêuticas, incluindo diabetes, oncologia, imunologia, neurociência e dor. Com sede em Indianápolis, Indiana, Lilly é conhecida por sua extensa P&D, desenvolvimento clínico e comercialização global de medicamentos biológicos e de pequenas moléculas. A empresa foca na descoberta de medicamentos, ensaios clínicos, aprovações regulatórias e fabricação e distribuição farmacêutica em larga escala.

Descrição

• Serve as the software quality subject-matter expert for internal and external systems and tools • Interpret CSV standards and external regulations and translate them into practical quality requirements • Own the digital quality strategy across the Catalyze360 portfolio • Lead design and implementation of the quality management system, design controls, and risk-management artifacts • Perform product and system risk assessments and drive corrective actions across engineering and product teams • Manage deviations, change control including AI/ML model change management, incidents, issues, root-cause investigations, and CAPAs • Serve as BQA/CSQA for critical internal business systems and review and approve related IT system documentation • Lead readiness efforts for internal and external audits • Coordinate internal stakeholders and third parties to resolve complex issues and prevent recurrence • Deliver quality data on compliance, conformance, model performance, cybersecurity posture, risks, and issues • Drive quality improvement and best-practice harmonization across internal teams and partner engagements • Evaluate software development lifecycle, QMS maturity, and AI/ML governance • Mobilize cross-functional teams across Lilly and third parties to embed quality into CI/CD pipelines • Serve as Catalyze360 Quality's principal digital quality contact for external engagements • Set expectations and build relationships across product, engineering, and subject-matter experts

🎯 Requisitos

• Bachelor's degree in a technology-related field, such as Computer Science, Software Engineering, Biomedical Engineering, or Information Systems • 6+ years of relevant industry experience in software quality for digital systems and tools or Computer System Validation with meaningful exposure to software • Experience embedding quality into product delivery for regulated software • Experience advising or consulting external companies on software quality, CSV/CSA, IT-controls, data privacy, and AI/ML governance • Completion of the CSQA Qualification Program upon hire, unless equivalent qualification is demonstrated • Certifications relevant to digital quality and IT controls • Working knowledge of IT regulations and standards • Broad IT and product technical competency, including AI/ML quality practices, information security, programming, data analytics, and cloud • Knowledge of modern software delivery practices, IT best practices such as LSEF and ITIL, and process-improvement methods such as Six Sigma • Excellent written and verbal communication, interpersonal, organizational, and negotiation skills • Ability to work effectively at all organizational levels and with external partners • Ability to operate autonomously across internal and external stakeholders • Proficiency with Microsoft Office • Proficient written and spoken English • Ability to travel up to 10% in the US and/or OUS • Relocation is not provided for this role

🏖️ Benefícios

• Company bonus depending on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program and fitness benefits • Employee clubs and activities