Senior Manager of Quality and Compliance
4 days ago
As a Senior Manager, Global Development Quality Management, you will be responsible for providing leadership and guidance on all aspects of quality and compliance within Global Development Quality systems. You will engage with key stakeholders, build strategic partnerships, and lead risk-based quality management activities on all Regeneron-sponsored clinical trials.
Responsibilities include:
- Serving as a Subject Matter Expert (SME) and key liaison to GDQ, providing support and advice on quality issues to ensure compliance and for the Quality Risk Assessment process.
- Developing and implementing Risk-Based Quality Management (RBQM) initiatives and process improvements in partnership with other functional areas.
- Providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management, audit responses, proactive quality management, and Corrective Action/Preventive Action (CAPA) oversight.
To be successful in this role, you will need advanced knowledge and understanding of GCP and GVP guidelines, experience serving as a subject matter expert/process owner/business process owner in a quality-related field, and advanced knowledge and application of risk-based approaches to quality management and oversight.
About Regeneron
Regeneron is a leading biotechnology company dedicated to discovering, developing, and delivering innovative medicines that transform lives. Our mission is to create life-changing treatments that address significant unmet medical needs, and we are committed to advancing science and innovation to improve human health.
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