Senior Manager GCP Quality

Build our future together:At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.When & where:Multiple locations are being considered for this role (Hybrid)Discover your role:Lead risk-based quality management across assigned clinical trialsDrive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysisPartner with study leads, monitoring teams, and contract research organisations on site risksEscalate significant quality events and trends to Executive Quality LeadershipSupport inspection readiness, responses, and follow-up actions across relevant functionsManage onboarding, development goals, coaching, performance discussions, and team administrationYou champion quality, integrity, continuous learning, and trusted partnershipsThis role requires:Bachelor’s degree and eight years’ relevant healthcare or pharmaceutical industry experienceQuality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experienceAdvanced risk-based quality management, risk assessment, and compliance knowledgeExperience managing complex issues, regulatory inspections, and inspection readinessSubject matter expert, process owner, training, presentation, and staff management experienceProcess improvement, project management, prioritisation, and time management skillsAdvanced Microsoft Outlook, Word, Excel, and PowerPoint skillsStrong communication, collaborationDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnes...

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