Global Quality Standards Manager
7 days ago
Role Overview
The Global Development Quality Standards & Continuous Improvement team is seeking a highly skilled professional to support the maintenance of our quality management system, ensure compliance with regulatory requirements, and drive continuous improvement initiatives.
Main Responsibilities:
- Support the GDQSCI team in activities related to QMS maintenance, quality event oversight, and process improvement.
- Collaborate with stakeholders across Global Development functions to identify process improvements and standardizations that impact the Regeneron quality system.
- Manage reporting and provision of quality-related metrics and trends to enable functional areas to achieve continuous improvement.
- Lead the Quality Event portfolio and provide SME expertise and guidance to relevant functional areas.
- Foster governance and oversight activities, including facilitation of oversight meetings and preparation/presentation of data supporting the health of the QMS.
Requirements:
- Bachelor's degree with a minimum of 6 years of relevant healthcare/pharmaceutical industry experience.
- Experience working in a quality/compliance role or Clinical Development with expertise in GCP and/or GVP guidelines.
- Strong knowledge of quality management systems, governance, and continuous improvement principles.
- Effective interpersonal relationships and collaboration skills.
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