Temporary Quality Manager – GCP

🔥 0 minutes ago

🌐 United Kingdom, United States, +1 more countries – Remote

🇬🇧 United Kingdom – Remote 🇺🇸 United States – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🔴 Lead

👔 Manager

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 10%

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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

• Engage Global Development stakeholders to drive process improvements, standardization, and regulatory compliance • Manage quality metrics and trend reporting to support continuous improvement • Oversee the Quality Event portfolio and provide subject matter expertise to functional teams • Lead quality data analysis, root cause investigations, and Corrective Action/Preventive Action development • Manage Quality System Metrics, including thresholds, reporting, actions, and effectiveness measures • Facilitate governance meetings and present data on Quality Management System health • Coordinate procedural document reviews and impact assessments across GDQGO • Promote quality culture and strengthen collaboration across Quality Management System elements • Support the Global Development quality system in a temporary role

🎯 Requirements

• Bachelor's degree • 6+ years of healthcare or pharmaceutical industry experience • Experience in Quality Management, Quality Assurance, or Clinical Development roles • Good Clinical Practice and/or Good Pharmacovigilance Practice expertise • Knowledge of Quality Management System oversight, governance, quality event management, and continuous improvement • Experience as a subject matter expert, process owner, or business process owner in a quality-related area • Experience delivering training and presenting quality and regulatory compliance information • Experience supporting or participating in regulatory agency inspections • Experience training, supervising, or mentoring staff • Strong project management, prioritization, organization, and time management skills • Strong communication, presentation, collaboration, and interpersonal relationship skills • Ability to identify process gaps, manage multiple priorities, and apply sound judgment with integrity and attention to detail • Ability to work in the UK, US, or Ireland

🏖️ 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 • Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses