Quality Compliance Specialist (Quality Risk Management)

Job Summary 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. Typical Day 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 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. This Role May Be For You If You Excel in a quality driven organization Have excellent collaboration, influence, and communication skills Are effective at facilitating cross-functional discussions Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required. Experience with Veeva heavily preferred. 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. To be considered for this role you must hold a Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering or related field and at least 2 years of relevant experience. May substitute proven experience for education requirement. Benefits We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. On-Site Policy Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Equal Opportunity Employer Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. Salary Range $67,400.00 - $110,000.00 #J-18808-Ljbffr Regeneron