Associate Director – Clinical Quality Assurance

Job not on LinkedIn

🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $117k - $189.2k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 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 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

• Lead and maintain GCP QA programs, policies, and procedures • Serve as primary GCP QA expert and point of contact • Ensure clinical programs comply with global health authority regulations and ICH guidelines • Provide QA oversight for protocols, ICFs, CSRs, and other trial documents • Monitor evolving GCP regulations and communicate impacts to stakeholders • Develop and execute global GCP audit strategies and annual plans • Conduct and manage audits of investigator sites, CROs, suppliers, systems, and documents • Prepare audit reports, evaluate CAPAs, and ensure effective follow-up • Lead inspection readiness activities and support FDA, EMA, MHRA, and other regulatory inspections • Partner with cross-functional teams and represent CQA on study teams • Contribute to protocol design and risk management • Collaborate on clinical quality procedures, forms, and templates • Identify compliance risks and implement mitigation strategies • Investigate quality issues, perform root cause analyses, and drive CAPA resolution • Prepare and present KPIs, metrics, and audit status updates to leadership • Develop and maintain GCP-related SOPs, training materials, and quality metrics • Lead process improvement initiatives across QA and the broader organization • Provide mentorship and leadership to QA staff, potentially including direct management

🎯 Requirements

• BS or higher in Life Sciences, Chemistry, Pharmacy, or related field • 8–10 years of experience in pharmaceutical quality roles • Experience with document control software such as ZenQMS, Veeva Vault, or MasterControl required • Knowledge of global health authority regulations, ICH guidelines, GCP, and industry standards

🏖️ Benefits

• Company bonus depending, in part, on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Certain 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