Sr Quality Compliance Specialist (Change Control)
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About The Position
We are currently looking to fill a Senior Quality Compliance Specialist, Quality Assurance position on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to facilitate partner relationships and oversee operational activities regarding partner change notifications. As a Senior Quality Compliance Specialist, Quality Assurance, a typical day might include acting as Regeneron's representative in meetings with external partners to discuss changes for applicable products, participating in internal cross-functional teams on global change management of partnered products, and sponsoring and advocating for Continuous Improvement activities. You will work with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures. In this role, you will develop relationships with end users and provide advice on best practices and strategy for changes that require partner notification. You will also be responsible for developing, monitoring, and communicating metrics to ensure the health of the partner notification process. Collaborating with counterparts to ensure global alignment of processes, systems, and procedures will be essential. Additionally, you will interpret compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation, assist as needed in audits and inspections, and review and approve Partner Change Notifications. Leading, mentoring, and developing direct reports will also be a key responsibility of this position.
