Senior Manager, Global Development Quality Assurance

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $134.4k - $219.2k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Post-IPO Equity on 2023-10

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Manage, hire and develop direct reports by meeting with direct reports at least monthly and conducting performance assessments. • Responsible for the training, resourcing, and individual staff development. • Schedule, prepare, conduct, report, and follow-up on audits in support of routine and directed GxP audits. • Represent the department by providing audit and compliance input in cross functional meetings. • Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements.

🎯 Requirements

• Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant industry experience • Deep knowledge of the FDA and EU regulations and ICH guidance documents • 5+ years of both direct people management and GCP audit experience preferred • Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs • Strong leadership with demonstrated ability to collaborate with both direct reports and senior leaders • Good problem solving, written and verbal communication skills.

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Insurance benefits (e.g. medical, dental, vision, life and disability) • Paid time off • Family support benefits