Senior Advisor – CSQA Representative, Catalyze360 Quality

🔥 1 minute ago

🏄 California, North Carolina, +1 more states – Remote

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

💵 $129k - $211.2k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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