Temporary Quality Manager GCP - GVP

Regeneron Pharmaceuticals

2d•Hybrid

About The Position

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 Temporary Quality Manager GCP - GVP, supporting our Global Development quality system in a hybrid work model. In this role, you will support quality management system governance, quality event oversight, and continuous improvement activities while collaborating with Global Development functions and quality leaders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Bachelor's degree and 6+ years of healthcare or pharmaceutical industry experience.
Experience in Quality Management, Quality Assurance, or Clinical Development roles with Good Clinical Practice and/or Good Pharmacovigilance Practice expertise.
Knowledge of Quality Management System oversight, governance, quality event management, and continuous improvement.
Experience as a subject matter expert, process owner, or business process owner in a quality-related area.
Experience delivering training and presenting quality and regulatory compliance information.
Experience supporting or participating in regulatory agency inspections.
Experience training, supervising, or mentoring staff.
Strong project management, prioritization, organization, and time management skills.
Strong communication, presentation, collaboration, and interpersonal relationship skills.
Ability to identify process gaps, manage multiple priorities, and apply sound judgment with integrity and attention to detail.

Responsibilities

Engage Global Development stakeholders to drive process improvements, standardization, and regulatory compliance.
Manage quality metrics and trend reporting to support continuous improvement.
Oversee the Quality Event portfolio and provide subject matter expertise to functional teams.
Lead quality data analysis, root cause investigations, and Corrective Action/Preventive Action development.
Manage Quality System Metrics, including thresholds, reporting, actions, and effectiveness measures.
Facilitate governance meetings and present data on Quality Management System health.
Coordinate procedural document reviews and impact assessments across GDQGO.
Promote quality culture and strengthen collaboration across Quality Management System elements.