Senior Manager, QA Auditor, GCP Strategy

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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

• Lead risk-based audit planning across therapeutic areas and studies • Drive strategic audit programs using risk indicators from study teams • Ensure audits align with approved programs and scheduled timelines • Manage audit outcomes to identify trends and communicate risks • Represent quality assurance on complex cross-functional initiatives • Deliver reports and metrics to Global Development leadership • Collaborate with stakeholders across global functions • Prioritize multiple complex activities while navigating ambiguity • Travel 10–20% as required

🎯 Requirements

• Bachelor’s degree with 8+ years of relevant industry experience • 5+ years of GCP audit strategy or audit experience • Knowledge of FDA, EU, and ICH GCP regulations and guidance • Experience supporting or participating in regulatory inspections • Strong project management and stakeholder management capabilities • Excellent written and verbal communication skills with senior audiences • Ability to travel 10–20% as required

🏖️ Benefits

• Remote work mode • 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 • Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses