Product Quality Manager

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $66k - $169.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Logo of Eli Lilly and Company

Eli Lilly and Company

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

• Oversee product quality activities across development and commercial-stage products • Ensure quality performance, compliance, and continuous improvement throughout the product lifecycle • Serve as Product Quality Lead for assigned programs • Investigate and finalize reporting activities for potential product complaints • Support Clinical Operations in evaluating product temperature excursions • Support manufacturing campaigns and release activities • Ensure archival and expedient retrieval of key manufacturing documentation • Review deviations, investigations, CAPAs, and change controls for adequacy • Analyze and report product quality trends • Facilitate risk assessments and mitigation activities and perform routine risk monitoring • Partner with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to support regulatory submissions • Support inspections and audits

🎯 Requirements

• BS/MS in Life Sciences • 5–10 years of pharmaceutical quality experience • Qualified applicants must be authorized to work in the United States on a full-time basis • Lilly will not provide support for or sponsor work authorization or visas • Knowledge of GMP manufacturing and quality systems • Adaptive problem-solving ability • Technical depth and growth mindset • Curiosity and drive for self-identified innovation, especially in artificial intelligence and digital

🏖️ Benefits

• Company bonus depending partly 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, fitness benefits, and employee clubs and activities • Employee resource groups and support networks • Accommodation support during the application process

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