Manager, Quality Assurance Auditor – GCP

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $114.8k - $187.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Own the end-to-end audit process, including scheduling, preparation, conducting, reporting, and follow-up • Lead routine and directed audits across investigator sites, vendors, license partners, and internal processes globally • Apply FDA, EU, and ICH regulations to resolve GCP compliance issues • Represent GDQA on cross-functional teams and complex compliance projects • Interpret regulations and quality standards and evaluate issues outside existing guidance • Develop and implement risk-based audit strategies with clinical study teams • Participate in regulatory inspections as part of control or inspection room teams • Mentor and onboard new GDQA staff

🎯 Requirements

• Bachelor's degree • 6+ years of relevant industry experience, including 4+ years of direct GCP audit experience • Background supporting risk-based audit strategy development for clinical studies • Experience applying FDA and EU regulations, including ICH E6 R3 and applicable standards • Ability to manage multiple complex priorities and make complex decisions with urgency • Strong project management, stakeholder management, collaboration, and negotiation skills • Ability to travel 30–40% of the time domestically and internationally

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life and disability insurance benefits • Paid time off • Family support benefits • Remote work model/flexibility