Job Description
The Quality System Specialist plays a crucial role in maintaining site compliance with mandated regulatory requirements and site expectations. This position oversees the implementation and use of the Quality Management System (QMS) and supports global elements of the QMS.
Main Responsibilities:
* Maintain regulatory compliance in accordance with current Good Manufacturing Practices (cGMP)
* Collaborate with cross-functional teams to resolve issues, complete investigations, and maintain compliance
* Review various system records for assignment, compliance, and closure
* Provide administrative support of electronic systems
* Review procedures, policies, and other instructional documents relating to quality systems
* Monitor and report on trending metrics associated with site quality systems
Requirements:
* Bachelor's degree in a scientific discipline
* 8+ years of experience in Pharma or Biotech for Principal Quality Systems Specialist
* 5+ years of experience in Pharma or Biotech for Senior Quality Systems Specialist
* Excellent written, oral, and interpersonal communication skills
* Strong time management, communication, and organizational skills
* Knowledge of quality and cGMP principles and systems
* Proficient in Microsoft Office Suite
About Regeneron
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and welcomes applications from qualified candidates without regard to race, color, religion, sex, nationality, national origin, civil status, age, citizenship status, military or veteran status, or any other protected characteristic.