Quality Compliance Specialist (Quality Risk Management)

Job description

We are currently looking to fill a Quality Compliance Specialist (Quality Risk Management) position. This position is responsible for supporting Regeneron’s Internal Drug Product Manufacturing operations through the use of quality risk management (QRM). Job functions will primarily consist of the broad application of patient centered QRM across a full spectrum of processes vital to the operations. Specifically, the active facilitation of quality risk assessments, risk reviews and other quality risk-based programs supporting the Quality System (e.g., change control, deviation management, etc.). The person in this role will be consistently challenged with assignments, touching almost every phase of our process. In this role, a typical day might include the following: Providing technical expertise in quality risk management to a broad base of customers throughout the organization, including Quality Assurance, Quality Control, Manufacturing, Medical Device and Facilities Facilitating data driven risk assessments and risk reviews using appropriate methodologies (e.g., FMEA, RBIA, REM and HACCP) Partnering with Risk Assessment Owners to define scope, acceptance criteria, and evaluation s...