Quality Compliance Specialist (Quality Risk Management)

Regeneron Pharmaceuticals•Rensselaer, NY

1d•$67,400 - $110,000•Onsite

About The Position

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.

Requirements

Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required.
Have an understanding of QRM principles
Are able to interpret complex technical and systems information and make sound risk-based decisions.
Are organized and have an attention to detail
Can prioritize multiple assignments and changing priorities
Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering or related field
2+ years of relevant work experience (for Specialist level)
5+ years of relevant work experience (for Sr Specialist level)
May substitute proven experience for education requirement.

Nice To Haves

Experience with Veeva heavily preferred.
Excellent collaboration, influence, and communication skills
Effective at facilitating cross-functional discussions

Responsibilities

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 scales
Guiding teams through risk identification, analysis, control/mitigation, and residual risk evaluation
Preparing and revising QRM documents
Developing and improving the quality risk management program
Contributing to contamination control strategy (CCS) and aseptic processing risk assessments for fill/finish operations; interface with EM, utilities, and equipment owners.
Preparing for and supporting regulatory, customer, and internal audits/inspections
Coaching colleagues on QRM principles and driving consistency in application
Tracking metrics (e.g., on-time risk reviews, cycle time) and identifying opportunities for continuous improvement.