Manager, Product Quality

🕒 5 days ago

🇺🇸 United States – Remote

💵 $66k - $169.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

✅ Product Manager

👻 Ghost score 0%

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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 global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 Description

• Serve as Product Quality Lead for assigned program(s) • 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 for expedient retrieval of key manufacturing documentation • Review deviations, investigations, CAPAs, and change controls for adequacy • Analyze and report on product quality trends • Facilitate development of risk assessments and mitigation activities • Perform routine risk monitoring activities • 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 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 for this role • Knowledge of GMP manufacturing and quality systems • Adaptive problem solver • Technical depth and a growth mindset • Curiosity and drive for self-identified innovation, especially in artificial intelligence and digital

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities

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