Temporary Quality Manager – GCP

🕒 il y a 20 jours

🌐 Royaume-Uni, États-Unis, +1 autres pays – Distant

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⏰ Temps Plein

🔴 Expert

👔 Manager

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

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👻 Score fantôme 10%

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🗣️🇺🇸🇬🇧 Anglais requis

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Regeneron

10 000+ employés

Fondée en 1988

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

💰 Post-IPO Equity en 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron est une entreprise de biotechnologie dédiée à la transformation des découvertes scientifiques en médicaments qui changent la vie. L’entreprise se concentre sur un large éventail de maladies graves, notamment les maladies allergiques, cardiovasculaires et métaboliques, ainsi que des domaines comme les neurosciences, l’oncologie, l’hématologie, l’ophtalmologie et les maladies rares. Elle y parvient en intégrant la biologie et la technologie pour développer des médicaments biologiques et des thérapies géniques de pointe. Regeneron s’engage en faveur de l’équité en santé, de la durabilité environnementale et du soutien aux talents STEM (sciences, technologie, ingénierie et mathématiques) de demain, notamment via des initiatives telles que le Regeneron Science Talent Search. En maintenant des normes éthiques élevées et une forte responsabilité sociétale, Regeneron vise à repousser les frontières de la science pour proposer de meilleures solutions de santé.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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

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