Manager, GD Quality Standards & Continuous Improvement (GCP)

The Manager, Global Development Quality Standards & Continuous Improvement (GDQSCI) will support the GDQSCI team with activities related to the maintenance of the Global Development Quality Management System (QMS), quality event oversight and improving processes for quality standards, governance, and oversight, as assigned.

This is a hybrid position with 3 days on-site requirement.

In this role, a typical day might include the following:

• Supporting the engagement of key stakeholders across Global Development functions to proactively identify process improvements, standardizations and regulatory compliance that impacts the Regeneron Global Development quality system.

• Responsible for managing the reporting and provision of quality-related metrics and trends to enable functions to continuous improvement.

• Responsible for managing the Quality Event (QE) portfolio and the provision of Subject Matter Expert (SME) expertise and guidance to relevant functional areas

• Responsible for governance and oversight activities, including facilitation of oversight meetings and preparation and presentation of data supporting the health of the QMS.

• Responsible for championing of the Quality Management System, including increasing awareness of the QMS within Global Development to influence quality culture.

This role may be for you if have:

• Knowledge, understanding and application of GCP, and/or GVP guidelines including the management of fundamental quality issues and compliance activities.

• Knowledge and understanding of quality management system (QMS) oversight, governance of quality processes, quality event oversight and continuous improvement.

• Effective management of interpersonal relationships and collaborations.

• Experience serving as a subject matter expert/process owner/business process owner in a quality related field/area.

• Experience in providing training and presenting information on key quality and regulatory compliance information.

To be considered for this opportunity we are looking for:

• Bachelor's degree with a minimum of 6 years of relevant healthcare/pharmaceutical industry experience. Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc..), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP).

$110,900.00 - $181,100.00